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MRD Watch

Sunday, November 15, 2026

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Research

Publications

Peer-reviewed papers, then conference abstracts. Each item is tagged by tumor type and assay. An assay name is a label for the test used in that paper, not a ranking.

Peer-reviewed papers

Hematologic MRD evidence

53 records, tagged by disease and evidence level. CASSIOPEIA is level 2. MRD was measured and was not used to assign therapy.

  • Level 1myelomapositive2024 · 2024-04-12

    FDA Oncologic Drugs Advisory Committee vote on MRD as an accelerated-approval endpoint in multiple myeloma

    Oncologic Drugs Advisory Committee, U.S. Food and Drug Administration. FDA ODAC meeting minutes.

    ODAC voted Yes 12, No 0, Abstain 0 on: 'Does the evidence support the use of MRD as an accelerated approval endpoint in MM clinical trials?' Committee discussion supported use in both newly diagnosed and relapsed/refractory settings, with 9-month, 12-month, and MRD-negative CR at any time considered acceptable assessment timepoints. Minutes approved July 2, 2024.

    IMF account of the vote

  • Level 1myelomapositive2026 · 2026-01-20

    Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval (Draft Guidance for Industry)

    U.S. Food and Drug Administration (OCE, CDER, CBER, CDRH). FDA draft guidance; Docket FDA-2025-D-2616. Bone-marrow flow cytometry or sequencing; threshold of at least 1 in 10^5

    Draft guidance, posted on the FDA site on January 20, 2026 (Federal Register notice January 21, 2026). Recommends MRD-negativity rate (in patients who have achieved CR or stringent CR), assessed in bone marrow by flow or sequencing, and CR rate as primary endpoints to support accelerated approval. MRD negativity should be assessed at a threshold of at least 1 in 10^5 residual tumor cells; alternate thresholds require justification. Verification of clinical benefit (typically PFS or OS) will generally be required, and confirmatory trial(s) should generally be underway prior to accelerated approval. Comments were due March 23, 2026.

    PDFFederal Register notice

  • Level 1myelomapositive2026 · 2026-08-13

    FDA accelerated approval of iberdomide (Zenbexus) with daratumumab and hyaluronidase-fihj and dexamethasone

    U.S. Food and Drug Administration. FDA Cancer Approvals. MRD-negative complete response at any time (EXCALIBER-RRMM) · n=420

    Accelerated approval on August 13, 2026, for adults with multiple myeloma after at least one prior line including a proteasome inhibitor and an immunomodulatory agent, in combination with daratumumab and hyaluronidase-fihj and dexamethasone. In the first 420 randomized patients (IberDd n=207 vs DVd n=213), MRD-negative CR at any time was 41% (95% CI 34-48) vs 21% (95% CI 15-27), p<0.0001. Continued approval may depend on confirmatory verification of clinical benefit. The trial remains ongoing for PFS.

    Prescribing information

  • Level 1myeloma/ALLpositive2018 · 2018-09-28

    FDA authorizes clonoSEQ, the first NGS-based MRD test for multiple myeloma and B-cell ALL

    U.S. Food and Drug Administration. FDA press announcement (De Novo DEN170080). clonoSEQ NGS, bone marrow

    On September 28, 2018, FDA granted De Novo authorization for Adaptive Biotechnologies' clonoSEQ assay to detect and monitor MRD in bone-marrow samples from patients with multiple myeloma or B-cell acute lymphoblastic leukemia, with the agency describing detection of remaining cancer cells at very low levels (down to about 1 in 1,000,000 cells).

    De Novo decision summary

  • Level 1ALLpositive2018 · 2018-03-29

    FDA expands blinatumomab (Blincyto) approval to MRD-positive B-cell precursor ALL

    U.S. Food and Drug Administration. FDA press announcement. MRD ≥10^-3 (0.1%) as the eligibility threshold in BLAST

    On March 29, 2018, FDA granted accelerated approval of blinatumomab for adults and children with B-cell precursor ALL in first or second complete remission with MRD ≥0.1%, based on the single-arm BLAST study. Supporting trial results are in Gökbuget et al., Blood 2018 (PMID 29358182).

  • Consensusmyelomapositive2016

    International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma

    Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, et al.. Lancet Oncol. PMID 27511158. Flow cytometry or sequencing MRD, with or without imaging

    IMWG defined MRD-negativity response categories (with or without imaging-based absence of extramedullary disease) to allow uniform reporting, using bone-marrow flow or sequencing plus sensitive imaging, on top of conventional CR.

  • Level 2myelomapositive2017

    Association of Minimal Residual Disease With Superior Survival Outcomes in Patients With Multiple Myeloma: A Meta-analysis

    Munshi NC, Avet-Loiseau H, Rawstron AC, Owen RG, Child JA, Thakurta A, et al.. JAMA Oncol. PMID 27632282. Heterogeneous MRD methods across included studies · n=1,273 (PFS, 14 studies); 1,100 (OS, 12 studies)

    Among 21 eligible studies, MRD negativity was associated with better PFS (HR 0.41, 95% CI 0.36-0.48, P<.001) and OS (HR 0.57, 95% CI 0.46-0.71, P<.001). In patients already in conventional CR, PFS HR was 0.44 (0.34-0.56) and OS HR 0.47 (0.33-0.67).

    Full text

  • Level 3myelomapositive2017

    Next Generation Flow for highly sensitive and standardized detection of minimal residual disease in multiple myeloma

    Flores-Montero J, Sanoja-Flores L, Paiva B, Puig N, García-Sánchez O, Böttcher S, et al.. Leukemia. PMID 28104919. EuroFlow NGF, bone marrow · n=110

    EuroFlow 2-tube 8-color NGF with acquisition of ≥10^7 cells; LOD <2×10^-6 and LOQ <5×10^-6. In 110 BM samples from patients in VGPR or CR, MRD-positive rate was 47% by NGF vs 34% by conventional 8-color flow (P=0.003); 25% of conventional MRD-negative cases were NGF-positive. NGF MRD-negative vs MRD-positive CR patients had longer PFS (75% PFS not reached vs 7 months; P=0.02).

    Full text

  • Level 2myelomapositive2020

    A large meta-analysis establishes the role of MRD negativity in long-term survival outcomes in patients with multiple myeloma

    Munshi NC, Avet-Loiseau H, Anderson KC, Neri P, Paiva B, Samur M, et al.. Blood Adv. PMID 33284948. Heterogeneous (flow and sequencing) across 44 studies · n=8,098 (PFS, 44 studies); 4,297 (OS, 23 studies)

    MRD negativity vs positivity improved PFS (HR 0.33, 95% CI 0.29-0.37, P<.001) and OS (HR 0.45, 95% CI 0.39-0.51, P<.001), including across newly diagnosed and relapsed/refractory disease, MRD thresholds, cytogenetic risk, and method of assessment.

    Full text

  • Level 2myelomapositive2020

    Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial

    Voorhees PM, Kaufman JL, Laubach J, Sborov DW, Reeves B, Rodriguez C, et al.. Blood. PMID 32325490. MRD (NGS, 10^-5) as a key secondary endpoint · n=207

    Randomized phase 2 trial of D-RVd vs RVd in 207 transplant-eligible NDMM patients. Primary endpoint, sCR by the end of post-ASCT consolidation, was 42.4% vs 32.0% (OR 1.57, 95% CI 0.87-2.82; 1-sided P=0.068), meeting the prespecified 1-sided alpha of 0.10. With median follow-up 22.1 months, sCR improved to 62.6% vs 45.4% (P=0.0177) and MRD negativity (10^-5, ITT) was 51.0% vs 20.4% (P<.0001). 24-month PFS 95.8% vs 89.8%. MRD analysis of a randomized phase 2 trial (level 2), not MRD-guided therapy.

    Full text

  • Level 2myelomamixed2022

    Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone With Minimal Residual Disease Response-Adapted Therapy in Newly Diagnosed Multiple Myeloma: The MASTER Trial (primary analysis)

    Costa LJ, Chhabra S, Medvedova E, Dholaria BR, Schmidt TM, Godby KN, et al.. J Clin Oncol. PMID 34898239. NGS MRD (clonoSEQ lineage), 10^-5 primary; 10^-6 also reported · n=123

    Single-arm phase 2 MRD-adapted Dara-KRd with AHCT (n=123). Primary endpoint MRD <10^-5: 80% overall (78%, 82%, and 79% for 0, 1, and 2+ HRCAs); 66% reached MRD <10^-6; 71% had two consecutive MRD-negative assessments and entered treatment-free surveillance. Two-year PFS was 87% (91%, 97%, and 58% for 0, 1, and 2+ HRCAs). 12-month incidence of MRD resurgence or progression after cessation was 4%, 0%, and 27% by HRCA group. Not a randomized trial, so filed as level 2 despite being MRD-guided.

  • Level 2myelomamixed2023

    Minimal residual disease response-adapted therapy in newly diagnosed multiple myeloma (MASTER): final report of the multicentre, single-arm, phase 2 trial

    Costa LJ, Chhabra S, Medvedova E, Dholaria BR, Schmidt TM, Godby KN, et al.. Lancet Haematol. PMID 37776872. NGS MRD, 10^-5 (MRD-evaluable n=118 of 123) · n=123

    Final analysis, median follow-up 42.2 months. Of 118 MRD-evaluable patients, 96 (81%, 95% CI 73-88) reached MRD <10^-5 and 84 (71%, 62-79) reached MRD-SURE and stopped therapy. 36-month PFS: 88% (no HRCA), 79% (1 HRCA), 50% (2+ HRCAs). Among 84 who stopped therapy, 24-month cumulative incidence of progression from cessation was 9%, 9%, and 47% by HRCA group. MRD-adapted cessation was feasible in 0-1 HRCA disease; patients with 2+ HRCAs had higher progression after stopping.

    Full text

  • Level 2myelomapositive2022

    Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): a randomised, open-label, multicentre, phase 3 trial

    Goldschmidt H, Mai EK, Bertsch U, Fenk R, Nievergall E, Tichy D, et al.. Lancet Haematol. PMID 36328040. Flow-cytometry MRD after induction (primary endpoint of part 1) · n=660

    Phase 3, 660 transplant-eligible NDMM patients (331 Isa-VRd, 329 VRd) in Germany. MRD negativity after induction (ITT) was reached in 166 (50%) vs 117 (36%) (OR 1.82, 95% CI 1.33-2.48; p=0.00017). Grade 3-4 neutropenia 23% vs 7%. MRD analysis of an RCT (level 2), not MRD-guided therapy. NCT03617731.

  • Level 2myelomapositive2025

    Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma: Final Part 1 Analysis of the GMMG-HD7 Trial

    Mai EK, Bertsch U, Pozek E, Fenk R, Besemer B, Hanoun C, et al.. J Clin Oncol. PMID 39652594. MRD after Isa-VRd vs VRd induction · n=662

    Final part 1 analysis of GMMG-HD7 (331 Isa-RVd, 329 RVd). MRD-negativity rates continued to deepen after transplant (66% Isa-RVd vs 48% RVd). Isa-RVd induction significantly prolonged PFS vs RVd regardless of maintenance (HR 0.70, 95% CI 0.52-0.95, P=0.0184). Level 2 (MRD and PFS analysis of a randomized trial).

    Full text

  • Level 2myelomapositive2024

    Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma (PERSEUS)

    Sonneveld P, Dimopoulos MA, Boccadoro M, Quach H, Ho PJ, Beksac M, et al.. N Engl J Med. PMID 38084760. MRD negativity as a key secondary endpoint (threshold as prespecified in the protocol; reported as MRD-negative status) · n=709

    Phase 3 trial, 709 transplant-eligible NDMM patients randomized to D-VRd (with D-R maintenance) vs VRd (with R maintenance). At median follow-up 47.5 months, 48-month PFS was 84.3% vs 67.7% (HR 0.42, 95% CI 0.30-0.59, P<0.001). CR or better 87.9% vs 70.1% (P<0.001); MRD-negative status 75.2% vs 47.5% (P<0.001). MRD analysis of an RCT (level 2), not MRD-guided therapy.

  • Level 2myelomapositive2024

    EVIDENCE meta-analysis: evaluating minimal residual disease as an intermediate clinical end point for multiple myeloma

    Landgren O, Prior TJ, Masterson T, Heuck C, Bueno OF, Dash AB, et al.. Blood. PMID 38768337. MRD negativity at 12±3 months (trial-level and individual-level association with PFS) · n=4907

    FDA-aligned meta-analysis of 8 newly diagnosed MM randomized trials (n=4,907). Trial-level association between 12-month MRD negativity and PFS: R²_WLSiv 0.67 (95% CI 0.43-0.91) and R²_copula 0.84 (0.64 to >0.99). Individual-level global OR for 12-month MRD negativity and PFS was 4.02 (95% CI 2.57-5.46) in NDMM and 7.67 (4.24-11.10) in 4 relapsed/refractory studies. Supported the case that a treatment effect on MRD is reasonably likely to predict a treatment effect on PFS. One of the two meta-analyses presented at the April 2024 ODAC.

    Full text

  • Level 2myelomapositive2025

    Minimal Residual Disease-Based End Point for Accelerated Assessment of Clinical Trials in Multiple Myeloma: A Pooled Analysis of Individual Patient Data From Multiple Randomized Trials (i2TEAMM)

    Shi Q, Paiva B, Pederson LD, Dimier N, Talpes E, Prior TJ, et al.. J Clin Oncol. PMID 39938021. MRD-negative CR at 10^-5, at 9 or 12 months · n=4773

    Individual-patient meta-analysis from 20 randomized trials; 11 studies (4,773 patients) evaluated 9- or 12-month MRD-CR at a 10^-5 threshold as an intermediate endpoint for PFS/OS in ND transplant-eligible, ND transplant-ineligible, and RRMM. Patient-level global ORs for MRD-CR and PFS ranged from 3.06 to 16.24 (all 95% CIs excluded 1.0). Trial-level R² 0.61-0.70 overall and 0.67-0.78 in newly diagnosed disease. Supported use of 9- or 12-month MRD-CR at 10^-5 as an intermediate endpoint for accelerated approval. This is the i2TEAMM pooled analysis presented at ODAC.

  • Level 2myelomapositive2025

    Isatuximab, carfilzomib, lenalidomide, and dexamethasone induction in newly diagnosed myeloma: analysis of the MIDAS trial

    Perrot A, Touzeau C, Lambert J, Hulin C, Caillot D, Karlin L, et al.. Blood. PMID 39841461. NGS MRD at 10^-5 and 10^-6 after Isa-KRd induction · n=791

    Induction analysis of the MRD-adapted MIDAS trial: 791 patients received six 28-day cycles of Isa-KRd. 96% completed induction; best ORR 95%; 91% achieved VGPR or better. In the ITT population, MRD-negativity rates after induction were 63% at 10^-5 and 47% at 10^-6.

    Full text

  • Level 1myelomamixed2025

    Measurable Residual Disease-Guided Therapy in Newly Diagnosed Myeloma (MIDAS)

    Perrot A, Lambert J, Hulin C, Pieragostini A, Karlin L, Arnulf B, et al.. N Engl J Med. PMID 40459097. NGS MRD, 10^-5 to assign consolidation; primary endpoint 10^-6 MRD negativity before maintenance · n=485 MRD-negative at 10^-5 after induction; 233 MRD-positive at 10^-5

    Phase 3 randomized MRD-guided consolidation after Isa-KRd induction. Among 485 patients MRD-negative at 10^-5 after induction, premaintenance MRD negativity at 10^-6 was 86% with ASCT + 2 cycles Isa-KRd vs 84% with 6 cycles Isa-KRd without ASCT (adjusted RR 1.02, 95% CI 0.95-1.10, P=0.64). Among 233 patients MRD-positive at 10^-5, premaintenance 10^-6 negativity was 32% with tandem ASCT vs 40% with single ASCT + Isa-KRd (adjusted RR 0.82, 95% CI 0.58-1.15, P=0.31). Median follow-up about 16-17 months. Neither intensification strategy significantly improved the 10^-6 MRD endpoint. Level 1 (randomized MRD-guided trial).

    Full text

  • Level 3myelomamixed2024

    Discontinuation of maintenance therapy in multiple myeloma guided by multimodal measurable residual disease negativity (MRD2STOP)

    Derman BA, Major A, Cooperrider J, Jiang K, Ramsland A, Karrison T, Kubicki T, Jakubowiak AJ. Blood Cancer J. PMID 39375362. Multimodal: PET, BM flow (LoD 10^-5), BM clonoSEQ (LoD 10^-6), plus CD138-enriched clonoSEQ toward 10^-7 · n=47

    Pragmatic trial: 47 patients with prior MRD <10^-5, ≥1 year of maintenance, and prospectively confirmed undetectable disease by PET, BM flow (10^-5), and BM clonoSEQ (10^-6) discontinued maintenance (median prior maintenance 36 months). Median post-discontinuation follow-up 30 months. Baseline MRD ≥10^-7 in 9/47 (19%). Estimated 3-year cumulative incidence of disease resurgence was 20% if baseline MRD <10^-7 vs 75% if ≥10^-7 (HR 7.8, 95% CI 2.2-27.6, P=0.001); 3-year PFS 92% vs 49% (HR 10.1, 95% CI 1.6-62.3). Small single-arm study (level 3).

    Full textASCO abstract 106ClinicalTrials.gov NCT04108624

  • Level 2myelomapositive2025

    Daratumumab-bortezomib-thalidomide-dexamethasone for newly diagnosed myeloma: CASSIOPEIA minimal residual disease results

    Corre J, Vincent L, Moreau P, Hebraud B, Hulin C, Béné MC, et al.. Blood. PMID 40127397. MRD at 10^-5 and 10^-6 at prespecified time points

    Long-term MRD and PFS after median follow-up 80.1 months. D-VTd improved MRD-negativity (10^-5) after induction (34.6% vs 23.1%) and consolidation (63.7% vs 43.7%) vs VTd. Daratumumab maintenance (fixed duration ≤2 years vs observation; not MRD-guided) further improved MRD-negativity (D-VTd/dara vs D-VTd/observation: 10^-5 77.3% vs 70.7%, 10^-6 60.7% vs 52.0%; VTd/dara vs VTd/observation: 10^-5 70.9% vs 51.2%, 10^-6 48.4% vs 30.7%) and provided PFS benefit regardless of post-consolidation MRD status. Correction: this is not an MRD-guided maintenance trial.

    Full text

  • Level 2myelomapositive2025

    Daratumumab plus bortezomib, lenalidomide and dexamethasone for transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: the randomized phase 3 CEPHEUS trial

    Usmani SZ, Facon T, Hungria V, Bahlis NJ, et al.. Nat Med. PMID 39910273. MRD negativity (and sustained MRD negativity) as a key endpoint · n=395

    Phase 3 D-VRd vs VRd in transplant-ineligible or transplant-deferred NDMM. At median follow-up 58.7 months, MRD-negativity rate 60.9% vs 39.4% (OR 2.37, 95% CI 1.58-3.55, P<0.0001); ≥CR 81.2% vs 61.6% (P<0.0001); sustained MRD negativity ≥12 months 48.7% vs 26.3% (P<0.0001). Risk of progression or death was 43% lower with D-VRd (HR 0.57, 95% CI 0.41-0.79, P=0.0005). Level 2. A dedicated MRD analysis is Zweegman et al., Blood Adv 2026 (PMID 42234958).

    Full text

  • Level 3myelomapositive2024

    Monitoring Minimal Residual Disease in Patients with Multiple Myeloma by Targeted Tracking Serum M-Protein Using Mass Spectrometry (EasyM)

    Fan H, Wang B, Shi L, Pan N, et al.. Clin Cancer Res. PMID 38170583. EasyM clonotypic serum mass spectrometry

    Method and clinical-monitoring paper for EasyM, a peripheral-blood clonotypic mass-spectrometry assay tracking serum M-protein for MRD in myeloma.

    Full text

  • Level 3myelomapositive2025

    Comparison of EasyM, a clonotypic mass spectrometry assay, and EuroFlow minimal residual disease assessment in multiple myeloma

    Zhao J, Khong T, Gorniak M, Khaled A, et al.. Haematologica. PMID 39506908. EasyM (serum MS) vs EuroFlow NGF (bone marrow)

    Head-to-head comparison of the blood-based EasyM clonotypic mass-spectrometry assay with EuroFlow bone-marrow MRD in myeloma (Haematologica 2025). The PubMed record did not include a structured abstract with numeric concordance rates at retrieval, so rates are not restated here; the paper and DOI were verified.

    Full text

  • Level 1myelomapending2019

    SWOG S1803 DRAMMATIC: daratumumab-lenalidomide vs lenalidomide maintenance with MRD-adapted duration in newly diagnosed myeloma after transplant

    SWOG / NCI NCTN. ClinicalTrials.gov. MRD-adapted maintenance duration

    Ongoing randomized MRD-adapted maintenance trial. No primary efficacy results paper was identified as of this review. Included as a level-1-design trial (MRD-integral randomization) without outcome data.

  • Level 2myelomapositive2026

    Daratumumab in transplant-ineligible or -deferred newly diagnosed multiple myeloma: minimal residual disease in CEPHEUS

    Zweegman S, Facon T, Hungria V, Bahlis NJ, et al.. Blood Adv. PMID 42234958. MRD at 10^-5 and 10^-6, including sustained MRD negativity · n=395

    395 patients (D-VRd 197, VRd 198), median follow-up 58.7 months. Overall MRD-negativity 10^-5: 60.9% vs 39.4% (OR 2.37, 95% CI 1.58-3.55, P<.0001); 10^-6: 46.2% vs 27.3% (OR 2.24, 95% CI 1.48-3.40, P=0.0001). Sustained MRD negativity ≥12 months 10^-5: 49.2% vs 27.3%; 10^-6: 34.0% vs 16.2% (each P<.0001), with similar benefits at ≥24 and ≥36 months. Among patients who achieved MRD negativity, PFS trended in favor of D-VRd (10^-5 HR 0.61, 95% CI 0.35-1.06, P=0.0755).

    Full text

  • Level 2ALLpositive2018

    Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia (BLAST)

    Gökbuget N, Dombret H, Bonifacio M, Reichle A, Graux C, Faul C, et al.. Blood. PMID 29358182. MRD ≥10^-3 at eligibility; complete MRD response after cycle 1 (primary endpoint) · n=116

    Open-label single-arm study: 116 adults with B-cell precursor ALL in hematologic CR with MRD ≥10^-3 received blinatumomab for up to 4 cycles. 88 of 113 evaluable patients (78%) achieved a complete MRD response after 1 cycle. In 110 Ph-negative patients, 18-month RFS was 54%; median OS 36.5 months. Complete MRD responders had longer RFS (23.6 vs 5.7 months, P=0.002) and OS (38.9 vs 12.5 months, P=0.002) than nonresponders. This trial supported the March 29, 2018 FDA approval. Single-arm (level 2); the approval itself is filed as regulatory level 1.

    Full text

  • Level 2ALLpositive2020

    Dasatinib-Blinatumomab for Ph-Positive Acute Lymphoblastic Leukemia in Adults (D-ALBA / GIMEMA LAL2116)

    Foà R, Bassan R, Vitale A, Elia L, Piciocchi A, Puzzolo MC, et al.. N Engl J Med. PMID 33085860. Molecular MRD in Ph+ ALL

    Chemo-free induction/consolidation with dasatinib followed by blinatumomab in adults with newly diagnosed Ph-positive ALL, with molecular MRD as a central response measure. Single-arm (level 2). Long-term results: Foà et al., J Clin Oncol 2024 (PMID 38127722).

  • Level 1ALLpositive2024

    Blinatumomab for MRD-Negative Acute Lymphoblastic Leukemia in Adults (E1910)

    Litzow MR, Sun Z, Mattison RJ, Paietta EM, et al.. N Engl J Med. PMID 39047240. Flow-cytometry MRD; MRD-negative defined as <0.01% leukemic cells in bone marrow · n=224

    Phase 3 trial in adults 30-70 years with BCR::ABL1-negative BCP-ALL who had MRD-negative remission after induction/intensification. 224 MRD-negative patients were randomized 1:1 to 4 cycles of blinatumomab plus consolidation chemotherapy vs chemotherapy alone. At median follow-up 43 months, 3-year OS was 85% vs 68% (HR for death 0.41, 95% CI 0.23-0.73, P=0.002); 3-year RFS 80% vs 64% (HR 0.53, 95% CI 0.32-0.87). Level 1 (randomized, MRD-defined eligibility).

    Full text

  • Level 1ALLpositive2025

    Blinatumomab in Standard-Risk B-Cell Acute Lymphoblastic Leukemia in Children (COG AALL1731)

    Gupta S, Rau RE, Kairalla JA, Rabin KR, et al.. N Engl J Med. PMID 39651791. MRD used in COG risk assignment (standard-risk average or higher risk of relapse) · n=1440

    Phase 3 trial of children with newly diagnosed standard-risk B-cell ALL at average or higher risk of relapse, randomized to chemotherapy alone (n=722) or chemotherapy plus two nonsequential 28-day blinatumomab cycles (n=718). Interim analysis led to early termination of randomization. At median follow-up 2.5 years, estimated 3-year DFS was 96.0±1.2% vs 87.9±2.1% (P<0.001). Among average-risk: 97.5±1.3% vs 90.2±2.3%; among higher-risk: 94.1±2.5% vs 84.8±3.8%. Level 1 (randomized; MRD contributes to COG risk groups).

    Full text

  • Level 2CLLpositive2018

    Venetoclax-Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia (MURANO)

    Seymour JF, Kipps TJ, Eichhorst B, Hillmen P, D'Rozario J, Assouline S, et al.. N Engl J Med. PMID 29562156. MRD as a key secondary/exploratory depth-of-response measure

    Phase 3 randomized venetoclax-rituximab vs bendamustine-rituximab in relapsed/refractory CLL, establishing fixed-duration Ven-R and high rates of undetectable MRD that were further analyzed in Kater et al., J Clin Oncol 2019 (PMID 30523712). Level 2.

  • Level 2CLLpositive2019

    Fixed Duration of Venetoclax-Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia Eradicates Minimal Residual Disease and Prolongs Survival: Post-Treatment Follow-up of the MURANO Phase III Study

    Kater AP, Seymour JF, Hillmen P, Eichhorst B, Langerak AW, Owen C, et al.. J Clin Oncol. PMID 30523712. Undetectable MRD after fixed-duration Ven-R

    Post-treatment MRD analysis of MURANO: fixed-duration venetoclax-rituximab produced high rates of undetectable MRD that were associated with longer survival. Level 2 (MRD analysis of an RCT).

  • Level 2CLLpositive2019

    Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions (CLL14)

    Fischer K, Al-Sawaf O, Bahlo J, Fink AM, Tandon M, Dixon M, et al.. N Engl J Med. PMID 31166681. Undetectable MRD as a key depth-of-response endpoint (fixed-duration Ven-O vs Clb-O)

    Phase 3 first-line venetoclax-obinutuzumab vs chlorambucil-obinutuzumab in patients with CLL and coexisting conditions. Fixed-duration Ven-O produced high MRD-undetectable rates and a PFS benefit, with subsequent MRD-dynamics papers (Al-Sawaf JCO 2021; 6-year Blood 2024). Level 2.

  • Level 2CLLpositive2021

    Minimal Residual Disease Dynamics after Venetoclax-Obinutuzumab Treatment: Extended Off-Treatment Follow-up From the Randomized CLL14 Study

    Al-Sawaf O, Zhang C, Lu T, Liao MZ, et al.. J Clin Oncol. PMID 34709929. Peripheral-blood MRD after end of fixed-duration Ven-O

    Extended off-treatment follow-up of CLL14 reporting MRD dynamics after venetoclax-obinutuzumab, including durability of undetectable MRD and its association with outcomes. Level 2.

    Full text

  • Level 2CLLpositive2024

    Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized phase 3 CLL14 study

    Al-Sawaf O, Robrecht S, Zhang C, Olivieri S, et al.. Blood. PMID 39082668. Long-term MRD and survival after fixed-duration Ven-O

    Six-year update of CLL14, including long-term PFS/OS and MRD outcomes after fixed-duration first-line venetoclax-obinutuzumab. Level 2.

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  • Level 1CLLpositive2021

    Ibrutinib Plus Venetoclax for First-Line Treatment of Chronic Lymphocytic Leukemia: Primary Analysis Results From the Minimal Residual Disease Cohort of the Randomized Phase II CAPTIVATE Study

    Wierda WG, Allan JN, Siddiqi T, Kipps TJ, et al.. J Clin Oncol. PMID 34618601. Confirmed undetectable MRD used to randomize subsequent therapy (placebo vs ibrutinib) · n=Confirmed uMRD: 43 placebo, 43 ibrutinib

    Previously untreated CLL, age <70: 3 cycles ibrutinib then 12 cycles ibrutinib-venetoclax. Best uMRD 75% (PB) and 68% (BM). Patients with confirmed uMRD were randomized 1:1 to placebo or ibrutinib. 1-year DFS was 95% with placebo vs 100% with ibrutinib (difference 4.7%, 95% CI -1.6 to 10.9; P=0.15). Supports the potential for fixed-duration therapy after confirmed uMRD. Level 1 (MRD-guided randomized cohort).

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  • Level 2CLLpositive2022

    Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort

    Tam CS, Allan JN, Siddiqi T, Kipps TJ, et al.. Blood. PMID 35196370. uMRD in PB and BM after fixed-duration I+V (not MRD-guided in this cohort)

    Fixed-duration (not MRD-guided) ibrutinib-venetoclax cohort. In the all-treated population, CR 55% (95% CI 48-63); best uMRD 77% (PB) and 60% (BM); 24-month PFS 95% and OS 98%. Level 2.

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  • Level 1CLLpositive2024

    Chronic Lymphocytic Leukemia Therapy Guided by Measurable Residual Disease (FLAIR)

    Munir T, Cairns DA, Bloor A, Allsup D, et al.. N Engl J Med. PMID 38078508. MRD-directed duration of ibrutinib-venetoclax (PB and BM MRD) · n=523

    Phase 3, previously untreated CLL: MRD-guided ibrutinib-venetoclax vs FCR (n=523). After 2 months of ibrutinib, venetoclax was added for up to 6 years, with duration guided by MRD. At median 43.7 months, progression or death occurred in 12 vs 75 patients (HR 0.13, 95% CI 0.07-0.24, P<0.001); death in 9 vs 25 (HR 0.31, 95% CI 0.15-0.67). At 3 years, 58.0% in the I+V group had stopped therapy because of undetectable MRD. After 5 years of I+V, 65.9% had undetectable MRD in BM and 92.7% in PB. Level 1 (randomized MRD-guided duration).

  • Level 1CLLpositive2025

    Measurable Residual Disease-Guided Therapy for Chronic Lymphocytic Leukemia (FLAIR, extended follow-up)

    Munir T, Girvan S, Cairns DA, Bloor A, et al.. N Engl J Med. PMID 40521799. Undetectable BM MRD within 2 years; MRD-guided I+V vs ibrutinib vs FCR · n=260 I+V, 263 ibrutinib, 263 FCR

    Extended follow-up (median 62.2 months) and increased enrollment. Undetectable BM MRD within 2 years: 172/260 (66.2%) with I+V vs 0/263 with ibrutinib alone (P<0.001) vs 127/263 (48.3%) with FCR. Progression or death: 18 (6.9%) I+V vs 59 (22.4%) ibrutinib (HR 0.29, 95% CI 0.17-0.49, P<0.001) vs 112 (42.6%) FCR (HR 0.13, 95% CI 0.08-0.21, P<0.001). 5-year PFS 93.9% vs 79.0% vs 58.1%. OS also favored I+V (HR 0.41 vs ibrutinib; HR 0.26 vs FCR). Level 1.

  • Level 2CLLpositive2023

    Impact of Minimal Residual Disease on Progression-Free Survival Outcomes After Fixed-Duration Ibrutinib-Venetoclax Versus Chlorambucil-Obinutuzumab in the GLOW Study

    Munir T, Moreno C, Owen C, Follows G, Benjamini O, Janssens A, et al.. J Clin Oncol. PMID 37279408. MRD after fixed-duration I+V (not MRD-guided)

    MRD analysis of the randomized GLOW trial of fixed-duration ibrutinib-venetoclax vs chlorambucil-obinutuzumab in older or comorbid first-line CLL, relating MRD status to PFS. Level 2 (MRD analysis of an RCT; therapy was fixed-duration, not MRD-guided).

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  • Level 2CLLpositive2023

    First-Line Venetoclax Combinations in Chronic Lymphocytic Leukemia (GAIA/CLL13)

    Eichhorst B, Niemann CU, Kater AP, Fürstenau M, von Tresckow J, Zhang C, et al.. N Engl J Med. PMID 37163621. Undetectable MRD in PB by flow at month 15, sensitivity <10^-4 (co-primary with PFS) · n=926

    Phase 3, 926 fit CLL patients without TP53 aberrations, randomized 1:1:1:1 to CIT (FCR or BR), Ven-R, Ven-O, or Ven-O-ibrutinib (12 cycles of venetoclax combinations). At month 15, undetectable MRD was 86.5% with Ven-O and 92.2% with Ven-O-I vs 52.0% with CIT (P<0.001 for both), and 57.0% with Ven-R (P=0.32 vs CIT). 3-year PFS 90.5% Ven-O-I vs 75.5% CIT (HR 0.32, 97.5% CI 0.19-0.54, P<0.001); 87.7% Ven-O (HR 0.42, P<0.001); 80.8% Ven-R (HR 0.79, P=0.18). Level 2 (MRD was a co-primary endpoint of a randomized trial, but treatment was not MRD-guided).

  • Level 2AMLpositive2016

    Assessment of Minimal Residual Disease in Standard-Risk AML (NPM1)

    Ivey A, Hills RK, Simpson MA, Jovanovic JV, et al.. N Engl J Med. PMID 26789727. RT-qPCR of NPM1-mutated transcripts in blood

    Persistence of NPM1-mutated transcripts in blood after the second chemotherapy cycle was present in 15% of patients and was associated with a greater 3-year relapse risk than absence of transcripts (82% vs 30%; HR 4.80, 95% CI 2.95-7.80, P<0.001) and lower survival (24% vs 75%; HR for death 4.38, 95% CI 2.57-7.47, P<0.001). MRD was the only independent prognostic factor for death in multivariate analysis (HR 4.84, 95% CI 2.57-9.15, P<0.001). Level 2. Foundational NPM1 MRD paper.

  • Level 2AMLpositive2020

    Impact of Conditioning Intensity of Allogeneic Transplantation for Acute Myeloid Leukemia With Genomic Evidence of Residual Disease

    Hourigan CS, Dillon LW, Gui G, Logan BR, et al.. J Clin Oncol. PMID 31860405. NGS genomic evidence of residual disease in blood before alloHCT (BMT CTN 0901)

    Among patients who were NGS-positive for residual disease before transplant, 3-year cumulative incidence of relapse was 19% with myeloablative conditioning (MAC) vs 67% with reduced-intensity conditioning (RIC) (P<.001); 3-year OS 61% vs 43% (P=0.02). In multivariable analysis of NGS-positive patients, RIC was associated with increased relapse (HR 6.38, 95% CI 3.37-12.10, P<.001), decreased RFS (HR 2.94, P<.001), and decreased OS (HR 1.97, 95% CI 1.17-3.30, P=0.01). Level 2 (MRD analysis of a randomized conditioning-intensity trial).

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  • ConsensusAMLpositive2021

    2021 Update on MRD in acute myeloid leukemia: a consensus document from the European LeukemiaNet MRD Working Party

    Heuser M, Freeman SD, Ossenkoppele GJ, Buccisano F, Hourigan CS, Ngai LL, et al.. Blood. PMID 34724563. ELN-standardized flow and molecular MRD

    Updated 2018 ELN MRD recommendations: technical guidance for flow- and molecular-MRD, MRD thresholds, definition of MRD response, and how results should be reported and combined when several techniques are used. Consensus document (not a trial).

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  • Level 2AMLpositive2024

    Measurable Residual FLT3 Internal Tandem Duplication Before Allogeneic Transplant for Acute Myeloid Leukemia

    Dillon LW, Gui G, Ravindra N, Andrew G, et al.. JAMA Oncol. PMID 38696205. NGS FLT3-ITD MRD in first-CR blood before alloHCT (Pre-MEASURE / MEASURE consortium lineage)

    Cohort study of DNA sequencing on first-CR blood from adults with FLT3-ITD AML before allogeneic transplant, examining the association between pre-HCT MRD level and post-transplant relapse and death. Level 2. Part of the MEASURE / Pre-MEASURE genomic MRD program led by Hourigan and colleagues.

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  • Level 2AMLpositive2024

    Gilteritinib as Post-Transplant Maintenance for AML With Internal Tandem Duplication Mutation of FLT3 (MORPHO)

    Levis MJ, Hamadani M, Logan B, Jones RJ, et al.. J Clin Oncol. PMID 38471061. FLT3-ITD MRD pre- and post-HCT (prespecified subgroup) · n=356

    356 participants randomized post-HCT to gilteritinib or placebo. Overall RFS difference was not statistically significant (HR 0.679, 95% CI 0.459-1.005, two-sided P=0.0518). 50.5% had MRD detectable pre- or post-HCT; in this prespecified subgroup, gilteritinib was beneficial (HR 0.515, 95% CI 0.316-0.838, P=0.0065), while those without detectable MRD showed no benefit (HR 1.213, 95% CI 0.616-2.387, P=0.575). Level 2 (RCT with prespecified MRD subgroup; not MRD-guided randomization).

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  • Level 2AMLpositive2025

    Measurable residual disease and posttransplantation gilteritinib maintenance for patients with FLT3-ITD-mutated AML

    Levis MJ, Hamadani M, Logan BR, Jones RJ, et al.. Blood. PMID 39775763. FLT3-ITD MRD in the MORPHO trial · n=356

    Dedicated MRD analysis of post-transplant gilteritinib maintenance in FLT3-ITD AML, expanding the prespecified MRD interaction reported in the 2024 JCO primary paper. Level 2.

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  • Level 2AMLpositive2024

    Postinduction molecular MRD identifies patients with NPM1 AML who benefit from allogeneic transplant in first remission

    Othman J, Potter N, Ivey A, Jovanovic J, et al.. Blood. PMID 38364112. Postinduction molecular NPM1 MRD

    Postinduction molecular MRD in NPM1-mutated AML used to identify patients who benefit from allogeneic transplant in first complete remission. Level 2.

  • Level 2lymphomapositive2018

    Circulating Tumor DNA Measurements As Early Outcome Predictors in Diffuse Large B-Cell Lymphoma

    Kurtz DM, Scherer F, Jin MC, Soo J, et al.. J Clin Oncol. PMID 30125215. CAPP-Seq ctDNA; early molecular response (EMR) and major molecular response (MMR) · n=217

    ctDNA dynamics from 217 patients at six centers, training and validation. Before therapy, ctDNA was detectable in 98%; pretreatment levels were prognostic in front-line and salvage settings. In the first validation set, front-line patients achieving EMR or MMR had superior 24-month EFS (EMR 83% vs 50%, P=0.0015; MMR 82% vs 46%, P<.001). EMR also predicted salvage 24-month EFS (100% vs 13%, P=0.011). Molecular response was independently prognostic including after adjustment for IPI and interim PET/CT. Level 2.

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  • Level 2lymphomapositive2025

    Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma

    Roschewski M, Kurtz DM, Westin JR, Lynch RC, et al.. J Clin Oncol. PMID 40802906. ctDNA MRD for remission assessment in LBCL

    ctDNA used to assess remission in large B-cell lymphoma, evaluating residual disease after therapy. Level 2. Complements earlier Kurtz 2018 work.

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  • Level 2lymphomapositive2026

    Prospective Validation of Circulating Tumor DNA Measurable Residual Disease After First-Line Therapy in Large B-Cell Lymphoma

    Wang S, Nijland M, Strobbe L, Oosterveld M, et al.. J Clin Oncol. PMID 41385760. PhasED-Seq ctDNA MRD at end of first-line therapy · n=136

    Prospective HOVON-902 cohort, curative-intent first-line treatment. Phased-variant identification successful in 134 of 136 (99%). At end of treatment, 83% were MRD-negative and 17% MRD-positive. 3-year PFS 17% vs 85% (HR 9.8, 95% CI 5.1-19, P=9.63×10^-12); OS 43% vs 92% (HR 7.7, 95% CI 3.4-17.4, P=1.27×10^-6). MRD positivity had higher PPV for 2-year PFS than positive PET (68% vs 56%, P≤.001); NPV similar (89% vs 88%). This is not a POLARIX analysis. Level 2.

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  • Level 2lymphomapositive2026

    Interim assessment by circulating tumor DNA in primary mediastinal large B-cell lymphoma: a multicenter LYSA study

    Camus V, Krzisch D, Bruscaggin A, Lévêque E, et al.. Blood Adv. PMID 41979332. Interim ctDNA in PMBCL (LYSA, NCT04980222)

    Multicenter LYSA study of interim ctDNA assessment in primary mediastinal large B-cell lymphoma. MRD detection after frontline therapy strongly complemented PET response criteria in predicting outcome. Level 2.

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  • Level 2lymphomapositive2026

    Circulating Tumor DNA Assessment of Disease Response in Large B-Cell Lymphoma: Lisocabtagene Maraleucel Versus Autologous Stem Cell Transplantation (TRANSFORM)

    Stepan L, Ansari S, Abramson JS, Okal A, et al.. J Clin Oncol. PMID 42044466. Ultrasensitive PhasED-Seq ctDNA at predefined time points · n=136

    Correlative ctDNA analysis of TRANSFORM (liso-cel vs salvage chemo + ASCT in second-line LBCL) in 136 patients. ctDNA clearance (MRD-neg) predicted longer EFS at all time points in both arms, with significantly more liso-cel-treated patients achieving MRD-neg. MRD-neg remained associated with EFS after adjusting for PET. Level 2.

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Conference abstracts

Meeting abstracts with a stable link. They are not full peer-reviewed papers.

The about page lists additional papers by the editor that are not repeated here when this index does not yet have a verified assay label for them.