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Multiple Myeloma Experience and Data

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Available evidence shows that clonoSEQ® may be used at multiple time points to help inform management1-4

Dig deeper into the clinical pathways using the green dots

Initial Diagnosis

Perform Clonality (ID) assessment from sample taken at time of diagnosis to establish tumor-specific B- and T-cell* receptor DNA sequences to track; use a fresh or archived bone marrow sample collected prior to initiation of treatment to enable future MRD assessment

the value of mrd

*T-cell testing is available as CLIA-validated LDT and has not been cleared or approved by the FDA.

Induction

Assess MRD in bone marrow post-induction

Informing treatment discontinuation

Autologous Stem Cell Transplant (ASCT)

Assess MRD in bone marrow post high-dose therapy/ASCT

Treatment vs transplant

Consolidation

Assess MRD in bone marrow post-consolidation

Download case studies

Maintenance

  • During maintenance, monitor MRD in the bone marrow at least every 12 months
  • In patients achieving sustained MRD negativity (defined as MRD negativity in the bone marrow at 2 consecutive time points a minimum of 1 year apart), consider whether to discontinue maintenance

MRD in maintenance settings

Initial Diagnosis

Perform Clonality (ID) assessment from sample taken at time of diagnosis to establish tumor-specific B- and T-cell* receptor DNA sequences to track; use a fresh or archived bone marrow sample collected prior to initiation of treatment to enable future MRD assessment

the value of mrd

*T-cell testing is available as CLIA-validated LDT and has not been cleared or approved by the FDA.

Induction

Assess MRD in bone marrow post-induction

Informing treatment discontinuation

Autologous Stem Cell Transplant (ASCT)

Assess MRD in bone marrow post high-dose therapy/ASCT

Treatment vs transplant

Consolidation

Assess MRD in bone marrow post-consolidation

Download case studies

Maintenance

  • During maintenance, monitor MRD in the bone marrow at least every 12 months
  • In patients achieving sustained MRD negativity (defined as MRD negativity in the bone marrow at 2 consecutive time points a minimum of 1 year apart), consider whether to discontinue maintenance

MRD in maintenance settings

Initial Diagnosis

Perform Clonality (ID) assessment from sample taken at time of diagnosis to establish tumor-specific B- and T-cell* receptor DNA sequences to track; use a fresh or archived marrow sample collected prior to initiation of treatment to enable future MRD assessment

the value of mrd

*T-cell testing is available as CLIA-validated LDT and has not been cleared or approved by the FDA.

D-Rd Therapy

  • According to NCCN Guidelines®, MRD assessment is indicated during therapy and post-induction as needed for prognostication
  • Consider evaluation of minimal residual disease (MRD) via bone marrow aspirate obtained at the time of best clinical response of very good partial response or better

clonoSEQ predicts PFS

*Not all multiple myeloma patients receive consolidation therapy.

Median time to a CR or better was 10.4 months.

Adaptive Biotechnologies does not recommend or endorse any particular course of treatment.

Other testing approaches may be medically appropriate and final testing decisions should be made by the patient’s healthcare provider. The results obtained from the clonoSEQ Assay should always be used in combination with the clinical examination, patient medical history, and other findings.

TRANSPLANT-ELIGIBLE PATHWAY TRANSPLANT-INELIGIBLE PATHWAY

Clinical vignette: Monitoring frequency post-transplant

Patient Scenario

Late 50s male diagnosed with multiple myeloma

Transplant eligible

Standard risk features

December 2018
Defining goals: Patient initiates RVd induction and proceeds to ASCT.

December 2019
Assessing response post-transplant: Patient is MRD-negative by clonoSEQ. Patient initiates lenalidomide maintenance therapy.

December 2020
Monitoring disease: One year into maintenance, the clonoSEQ result remains MRD-negative. Physician and patient decide to discontinue maintenance therapy and closely monitor the patient’s MRD.

Adaptive Biotechnologies does not recommend or endorse any particular course of treatment.


View additional real-world case studies that inform care

See how Dr. Saulius Girnius uses MRD to predict outcomes.

watch video
see other case studies

Peer-reviewed data show how clonoSEQ is a
clinically valuable prognostic indicator

In large scale analyses of newly diagnosed and relapsed/refractory multiple myeloma patients, MRD negativity strongly predicted outcomes8,9

MRD negativity was associated with longer PFS in patients who achieved CR, with those reaching durable MRD negativity experiencing even greater benefit.

About the study

This pooled analysis of 4 randomized, open-label studies (ALCYONE, MAIA, CASTOR, POLLUX) of daratumumab-based combination regimens in transplant-ineligible newly diagnosed and relapsed/refractory multiple myeloma (n = 2510) assessed the prognostic value of MRD negativity at 10-5 in patients who achieved at least a complete response.

About the study

This pooled analysis of 2 randomized, open-label studies (ALCYONE, MAIA) of daratumumab-based combination regimens in transplant-ineligible newly diagnosed multiple myeloma (n = 1443) assessed the prognostic value of sustained MRD negativity (10-5) for ≥ 12 months vs MRD negativity for < 12 months and MRD positivity.


clonoSEQ identified more MRD-positive patients than MFC, and those patients achieved worse outcomes7

In multiple myeloma pre- and post-maintenance, 40% to 50% of patients originally MRD-negative by MFC were identified to have residual disease by clonoSEQ due to greater sensitivity.

About the study

Additional 84 MRD-positive patients identified

One hundred sixty-three multiple myeloma patients initially identified as MFC MRD-negative were assessed by clonoSEQ. Of the clonoSEQ-assessed patients, 84 were identified as MRD-positive. These 84 patients had worse PFS compared to patients who were MRD-negative by MFC and clonoSEQ.

About the study

Additional 42 MRD-positive patients identified

One hundred eleven multiple myeloma patients initially identified as MRD-negative by MFC were assessed by clonoSEQ. Of these 111 patients, 42 were identified as MRD-positive by clonoSEQ. These patients had worse PFS compared to patients who were MRD-negative by MFC and clonoSEQ.


In newly diagnosed multiple myeloma patients receiving maintenance therapy, MRD negativity was shown to be the strongest predictor of PFS10

MRD status more effectively predicted outcomes than traditional risk factors, irrespective of disease stage or cytogenetics.

About the study

In the IFM 2009 study, 509 newly diagnosed multiple myeloma patients received RVd +/- transplant followed by 12 months of lenalidomide maintenance therapy. An analysis of the 239 patients with known MRD status after completion of maintenance therapy was performed to determine whether cytogenic risk or ISS stage modifies the relationship between MRD 10-6 and outcomes.

High-risk cytogenetics defined as the presence of 17p deletion or either t(4;14) or t(14;16) translocation.

§Stages II and III grouped together, as hazard ratios in these subgroups were numerically identical.

Advanced MRD assessment starts today

Contact Adaptive about ordering clonoSEQ
through our single-site laboratory.

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NCCN Guidelines®

Clinical Practice Guidelines recommend MRD testing in multiple myeloma

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)1

Diagnostic workup
Consider baseline clone identification and storage of aspirate sample for future MRD testing by NGS.

MRD assessment:

  • MRD testing is recommended at multiple times during and after treatment
  • Consider MRD as indicated for prognostication after shared decision with patient

visit the NCCN website

Not all multiple myeloma patients receive consolidation therapy.

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.


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 minimal 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). clonoSEQ is also available for use in other lymphoid cancers and specimen types as a CLIA-validated laboratory developed test (LDT). For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.

References

  • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.1.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed August 31, 2021. 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.
  • Costa L, et al. EHA 20‌20. EP‌928
  • ClinicalTrials.gov. NCT01208662. Accessed June 2, 2021.
  • Vij R, et al. Clin Lymphoma Myeloma Leuk. 2014;14(2):13‌1-13‌9.
  • Facon T, et al. N Engl J Med. 2019;380(22):210‌4-21‌15.
  • Kumar S, et al. Blood. 2020. 136 (Supplement 1):24-26.
  • Avet-Loiseau H, et al. Blood. 201‌5;12‌6(23):191.
  • Cavo M, et al. Blood. 2021. doi: 10.11‌82/blood.202‌1011101
  • San-Miguel J, et al. Blood. 2021. doi: 10.1182/blood.2020‌010439
  • Perrot A, et al. Blood. 2018;132(23):245‌6-2‌464.