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

Risk Stratification and MRD-driven Maintenance for Multiple Myeloma After Autologous Stem Cell Transplantation

This study is testing if different maintenance treatments after stem cell transplantation can help people with multiple myeloma feel better, depending on their risk level and if they still have cancer cells in their blood.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: daratumumab
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT06697483 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are newly diagnosed multiple myeloma patients who have undergone at least 4 cycles of induction therapy and ASCT within the last 12 months.

Not a fit: Patients who are refractory or intolerant to lenalidomide or daratumumab, or those with progressive disease, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective maintenance therapies for multiple myeloma patients, potentially improving survival rates.

How similar studies have performed: Other studies have shown promising results with similar maintenance strategies in multiple myeloma, indicating potential for success in this approach.

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.

Where this trial is running

Beijing, Beijing Municipality and 3 other locations

• 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.

Conditions Multiple Myeloma; R2-ISS stage; Minimal Residual Disease; Lenalidomide; Daratumumab