NCT06697483Recruiting
Risk Stratification and MRD-driven Maintenance for MM After ASCT
Risk Stratification and MRD-driven Maintenance for Multiple Myeloma After Autologous Stem Cell Transplantation
Source: ClinicalTrials.gov · Last updated 25 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 18 Nov 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Multiple myeloma
- NCT number
- NCT06697483
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Dec 2024 to the primary completion date, 31 Dec 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Must not have progressed on multiple myeloma (MM) therapy before screening
- History of stroke or serious thrombotic event within 12 months prior to screening.
Other illness
- Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50 % of predicted normal;
Other
- Must not refractory or non-tolerate to lenalidomide in Arm A.
- Must not refractory or non-tolerate to lenalidomide and daratumumab in Arm B.
- Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
Who the study is looking for
- 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.
- Must have a partial response (PR) or better response before maintenance.
- Must have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2.
- This study allows for post-ASCT consolidation therapy.
- 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%).
- No active infection.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Fuxing Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.