Risk Stratification and MRD-driven Maintenance for MM After ASCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lenalidomide

For patients with low-risk or intermediate-low risk and minimal residual disease negativity before maintenance

Group Type OTHER

Lenalidomide

Intervention Type DRUG

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.

Daratumumab and Lenalidomide

For patients with high-risk or intermediate-high risk OR minimal residual disease posivitity before maintenance

Group Type OTHER

Daratumumab

Intervention Type DRUG

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

Lenalidomide

Intervention Type DRUG

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.

Interventions

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Daratumumab

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No