NEW: Updated NCCN MM Guidelines Strengthen Recommendation for Baseline Clonotype ID at Diagnosis. 
Covered by Medicare and FDA-cleared, clonoSEQ supports baseline ID assessment to enable subsequent next generation sequencing (NGS)-based MRD tracking.   For more info about incorporating clonoSEQ into your clinical practice for MM patients, click here. 

Multiple Myeloma

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

FDA-cleared in bone marrow and CLIA-validated in peripheral blood

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

clonoSEQ provides helpful evidence of disease when considering treatment discontinuation.1,2

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

≥80%

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

Informing changes in therapy

Confidently make treatment decisions based on clonoSEQ results.

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

MRD positive:

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

MRD negative:

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

Achieving MRD negativity with clonoSEQ is associated with better outcomes regardless of therapy used.4

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

Deeper responses detected by clonoSEQ are associated with better outcomes.

Depth matters:

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

Duration matters:

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

When patients are cleared of disease, clonoSEQ MRD status can help predict what comes next.8

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

clonoSEQ provides greater predictive insights than MRD by multiparameter flow cytometry (MFC).5

40-50%

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

Leverage the clinical insights of clonoSEQ MRD testing
across treatment phases in multiple myeloma

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

Induction

Initiating clonoSEQ MRD assessment after induction can help inform subsequent treatment decisions1

Transplant

clonoSEQ can be assessed after transplant to determine the response to treatment and inform next steps4

Consolidation

clonoSEQ can help you and your patient decide whether to make any adjustments to therapy1

Maintenance

Monitoring MRD dynamics with clonoSEQ provides you the confidence to decide whether to modify, discontinue, or stay the course2§

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

clonoSEQ is featured in the National Community Oncology Dispensing
Association (NCODA) Positive Quality Intervention for Multiple Myeloma.12

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

Download

Coverage throughout a patient’s treatment journey

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‖

View the clonoSEQ Multiple Myeloma
Clinical Data Summary

Download

Ready to get started with clonoSEQ?

Order clonoSEQ

ctDNA MRD Testing Now Included in DLBCL Clinical Practice Guidelines

Clinical practice guidelines now include ctDNA MRD testing after frontline therapy for PET-positive DLBCL patients.

clonoSEQ is the only commercially available, Medicare-covered, ctDNA MRD test for DLBCL patients.

*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 clonoSEQ.com/technical-summary.

References:

  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.org. 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. https://www.ncoda.org/pqis/