NCT06697483 Risk Stratification and MRD-driven Maintenance for MM After ASCT
| NCT ID | NCT06697483 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06697483 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06697483 currently recruiting?
Yes, NCT06697483 is actively recruiting participants. Contact the research team at pkuphliuyang@bjmu.edu.cn for enrollment information.
Where is the NCT06697483 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Harbin, China.
Who is sponsoring the NCT06697483 clinical trial?
NCT06697483 is sponsored by Peking University People's Hospital. The trial plans to enroll 100 participants.