Multiple Myeloma

Advances in multiple myeloma therapies demand MRD measurement with the clarity and accuracy that clonoSEQ provides

The depth and duration of molecular remissions achieved by new treatments are increasingly playing a critical role in guiding decisions to change therapy or providing reassurance to stay the course. clonoSEQ can quantify measurable residual disease (MRD) at the deepest level clinically available, so even small changes in residual disease levels can be detected and used to inform decisions to initiate, modify, or discontinue therapy.1-3

With the ability to quantify MRD at a depth of 10-6*, clonoSEQ enables personalized decision-making throughout an ever-changing continuum of care

Truly personalized decisions

In the MASTER trial, patients underwent MRD testing post-induction, post-transplant, and during consolidation and could proceed to treatment-free surveillance after 2 consecutive MRD-negative tests.1

3-year PFS in standard (0 HRCA) or high-risk patients (1 HRCA) in treatment-free surveillance1†

Informing changes in therapy

In an analysis of real-world data, patient MRD status led to modifications in therapy and impacted outcomes.2

Changing or intensifying therapy led to better progression-free survival (PFS) vs those who didn’t.2

Discontinuing therapy had no significant impact on PFS vs those who continued.2

When clonoSEQ guides the choice to discontinue therapy, some patients may be spared the related physical and financial consequences of continued therapy1,2

Prognostic insight

In the DETERMINATION trial, patients who were MRD negative by clonoSEQ at the start of maintenance therapy had similar 5-year PFS, whether they had received an early transplant (53.5%) or not (59.2%).4

Understanding disease

Patients who had MRD negativity <10-6 had better PFS1,5-7 and overall survival (OS)5,6 compared to those with detectable MRD.*

Sustained MRD negativity with clonoSEQ was associated with better OS and PFS.1,5‡

In patients with 0 or 1 high-risk cytogenetic abnormalities (HRCA), MRD status more effectively predicted outcomes than traditional risk factors, irrespective of disease stage5

Complete response isn’t the complete picture

In a pooled analysis of 4 studies of relapsed/refractory or transplant ineligible patients, patients who achieved a complete response (CR) or better and who were MRD negative by clonoSEQ had longer PFS compared to those who were MRD positive.

Sensitivity that goes deeper


of patients who were MRD negative by MFC actually still had residual disease detected by clonoSEQ9

clonoSEQ blood-based testing offers a minimally invasive, quantitative MRD result that can complement regular bone marrow assessment, letting you monitor disease burden more frequently than a bone marrow draw10

Clinical practice guidelines and clinical trial data support regular MRD testing at multiple timepoints during and after active treatment.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend MRD testing in multiple myeloma at induction, after transplant, at consolidation, and during maintenance.11§

Explore an overview of the utility of clonoSEQ in assessing MRD in patients with multiple myeloma over the course of treatment.

clonoSEQ is well covered, regardless of a patient’s insurance.

  • National Medicare coverage for myeloma patients at multiple testing timepoints with most patients paying $0 out-of-pocket
  • Positive coverage policies from the largest national private insurers

*Given sufficient sample material.

Standard risk, 0 HRCA; high risk, 1 HRCA.

Sustained MRD negativity defined as 2 consecutive MRD-negative tests 1 year apart.

§NCCN makes no warranties of any kind whatsoever regarding its content use, or application and disclaims any responsibility for how its content is applied or used, in any way.

Medicare Advantage patients may have out-of-pocket costs.

About the studies

MRD Surveillance

MASTER was a multicenter, single-arm, phase 2 trial of patients with newly diagnosed multiple myeloma (NDMM), conducted by Costa et al. Patients received Dara-KRd induction, autologous stem cell transplants (ASCT), and Dara-KRd consolidation, according to MRD status. MRD was evaluated by next-generation sequencing (NGS) at the end of induction, post-ASCT, and every 4 cycles (maximum of 8 cycles) of consolidation. Primary endpoint was achievement of MRD negativity (10-5). Subjects with 2 consecutive MRD-negative assessments entered treatment-free MRD surveillance.1

MRD at Start of, During, and/or 12 Months Post Maintenance Therapy

In a retrospective review of 400 patients with NDMM and relapsed/refractory multiple myeloma who had at least 1 MRD assessment, Martinez-Lopez et al explored how clinical decisions made based on MRD results affected outcomes. MRD was assessed by MFC or clonoSEQ with sensitivity from 10-5 to 10-6. Treatment intensification or change was made during maintenance therapy in 83% of subjects.2

DETERMINATION was a phase 3 trial evaluating lenalidomide + bortezomib + dexamethasone (RVd) alone or RVd + ASCT in patients with NDMM (n = 357). MRD was assessed by clonoSEQ (10-5) from the start of lenalidomide maintenance therapy in 108 patients in the RVd-alone group and 90 patients in the RVd + ASCT group. RVd plus transplant resulted in better PFS than with RVd alone, but OS did not differ.4

MRD Meta-Analysis

Munshi et al. conducted a large meta-analysis comprised of 44 studies with PFS data (n = 8,098) and 23 studies with OS data (n = 4,297) which assessed the association between MRD status and survival outcomes.6

clonoSEQ vs MFC

In the Intergroupe Francophone du Myelome (IFM) 2009 study, patients at pre-maintenance and post-maintenance timepoints who were identified as MFC MRD
negative (10-4) were assessed by clonoSEQ (10-6). Of these patients, 84 and 42, respectively, were identified as MRD positive.9

Bone Marrow/Peripheral Blood Concordance

The concordance of clonoSEQ between bone marrow and peripheral blood was assessed in paired samples from 60 patients. Myeloma clones were detected in bone marrow samples from 48 patients and in peripheral blood from 46 patients.10

This page is intended for a US-based audience.

clonoSEQ® is available as an FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies to detect measurable residual disease (MRD) in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). Additionally, clonoSEQ is available for use in other lymphoid cancers and specimen types as a CLIA-validated laboratory developed test (LDT). To review the FDA-cleared uses of clonoSEQ, visit


  1. Costa L, et al. Lancet Haematol. 2023;10(11):e890-e901.
  2. Martinez-Lopez J, et al. J Hematol Oncol. 2021;14(1):126.
  3. Sonneveld P, et al. N Engl J Med. 2024;390(4):301-313.
  4. Richardson P, et al. N Engl J Med. 2022;387(2):132-147.
  5. Perrot A, et al. Blood. 2018;132(23):2456-2464.
  6. Munshi N, et al. Blood Adv. 2020;4(23):5988-5999.
  7. Costa L, et al. J Clin Oncol. 2021;40(25):2901-2912.
  8. Cavo M, et al. Blood. 2022;139(6):835-844.
  9. Avet-Loiseau H, et al. Blood. 2015;126(23):191.
  1. Vij R, et al. Clin Lymphoma Myeloma Leuk. 2014;14(2):131-139.
  2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.2.2024. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed January 23, 2024. To view the most recent and complete version of the guideline, go online to NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  3. National Community Oncology Dispensing Association (NCODA). Positive Quality Interventions (PQIs). Accessed January 18, 2024.