Risk Stratification and MRD-driven Maintenance for MM After ASCT

Not Applicable

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: Lenalidomide; Drug: Daratumumab

• Registration Number: NCT06697483
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Study Start: 2024-12-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lenalidomide	Lenalidomide	For patients with low-risk or intermediate-low risk and minimal residual disease negativity before maintenance
Daratumumab and Lenalidomide	Daratumumab	For patients with high-risk or intermediate-high risk OR minimal residual disease posivitity before maintenance
Daratumumab and Lenalidomide	Lenalidomide	For patients with high-risk or intermediate-high risk OR minimal residual disease posivitity before maintenance

Primary Outcome Measures

Name	Time	Method
MRD (Minimal Residual Disease) status at 12 months after maintenance	12 months	Bone marrow minimal residual disease status at 12 months after maintenance

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Fuxing Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China