Risk Stratification and MRD-driven Maintenance for MM After ASCT

November 20, 2024 updated by: Jin Lu, MD, Peking University People's Hospital

Risk Stratification and MRD-driven Maintenance for Multiple Myeloma After Autologous Stem Cell Transplantation

This study evaluates the maintenance strategy based on risk stratification and MRD status after stem cell transplantation.

This is a single-arm, multicenter, prospective study. Participants who are R2-ISS 1,2 and MRD negative receive the single drug lenalidomide maintenance. In other circumstances, for example, patients who are R2-ISS 3 or 4 will receive daratumumab combined with lenalidomide regardless of MRD status, while patients with MRD positivity will also receive daratumumab plus lenalidomide maintenance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, Beijing, China, 100038
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT.
  2. Must have a partial response (PR) or better response before maintenance.
  3. Must have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2.
  4. This study allows for post-ASCT consolidation therapy.
  5. ANC ≥ 1.0 x 10^9/L, Hb ≥ 85 g/L PLT ≥ 75 x 10^9/L (if BMPC < 50%) or PLT ≥ 50 x 10^9/L (if BMPC ≥ 50%).
  6. No active infection.
  7. a).TBIL<1.5 x upper limit of normal (ULN) (<3 x ULN in patients with Gilbert's syndrome); b).AST and ALT <3 x ULN.; c. Creatinine clearance ≥ 45mL/min.

Exclusion Criteria:

  1. Must not refractory or non-tolerate to lenalidomide in Arm A.
  2. Must not refractory or non-tolerate to lenalidomide and daratumumab in Arm B.
  3. Must not have progressed on multiple myeloma (MM) therapy before screening
  4. Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50 % of predicted normal；
  5. Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
  6. History of stroke or serious thrombotic event within 12 months prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lenalidomide
For patients with low-risk or intermediate-low risk and minimal residual disease negativity before maintenance
Drug: Lenalidomide

Patients are R2-ISS 1,2 and MRD (Minimal Residual Disease) negative after autologous stem cell transplantation.

Patients will receive the single drug lenalidomide maintenance.
Other: Daratumumab and Lenalidomide
For patients with high-risk or intermediate-high risk OR minimal residual disease posivitity before maintenance
Drug: Lenalidomide

Patients are R2-ISS 1,2 and MRD (Minimal Residual Disease) negative after autologous stem cell transplantation.

Patients will receive the single drug lenalidomide maintenance.

Drug: Daratumumab
Patients who are R2-ISS 3 or 4 OR MRD (Minimal Residual Disease) positivity will receive daratumumab plus lenalidomide maintenance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRD (Minimal Residual Disease) status at 12 months after maintenance
Time Frame: 12 months
Bone marrow minimal residual disease status at 12 months after maintenance
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CR+VGPR
Time Frame: 12 months
complete response plus very good partial response at 12 months from maintenance
12 months
Estimated 3 year-PFS
Time Frame: 3 years
Estimated 3 year progression free survival
3 years
Estimated 3 year OS
Time Frame: 3 years
Estimated 3 year overall survival
3 years
TRAEs
Time Frame: 3 years
Treatment related adverse events
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024PHB165-001-20240930

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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