Maintenance treatment for multiple myeloma after stem cell transplantation based on risk and MRD status

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a maintenance treatment strategy for patients with multiple myeloma who have undergone autologous stem cell transplantation (ASCT). It is a single-arm, multicenter, prospective study where patients are stratified based on their risk and minimal residual disease (MRD) status. Those with lower risk and MRD negativity will receive lenalidomide alone, while higher-risk patients or those with MRD positivity will receive a combination of daratumumab and lenalidomide. The goal is to determine the effectiveness of these tailored maintenance therapies in improving patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fuxing Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Recruiting

Study contacts

• Study coordinator: Yang Dr, M.D.
• Email: pkuphliuyang@bjmu.edu.cn
• Phone: +86-10-88326542

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.