Risk Stratification and MRD-driven Maintenance for MM After ASCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Daratumumab, Lenalidomide.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Risk Stratification and MRD-driven Maintenance for Multiple Myeloma After Autologous Stem Cell Transplantation
Overview
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.
Interventions
- Drug Daratumumab
Patients who are R2-ISS 3 or 4 OR MRD (Minimal Residual Disease) positivity will receive daratumumab plus lenalidomide maintenance. - Drug Lenalidomide
Patients are R2-ISS 1,2 and MRD (Minimal Residual Disease) negative after autologous stem cell transplantation. Patients will receive the single drug lenalidomide maintenance.
Primary outcome measures
- MRD (Minimal Residual Disease) status at 12 months after maintenance [Time frame: 12 months]
Secondary outcome measures (4)
- CR+VGPR [Time frame: 12 months]
- Estimated 3 year-PFS [Time frame: 3 years]
- Estimated 3 year OS [Time frame: 3 years]
- TRAEs [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Must not refractory or non-tolerate to lenalidomide in Arm A.
- Must not refractory or non-tolerate to lenalidomide and daratumumab in Arm B.
- Must not have progressed on multiple myeloma (MM) therapy before screening
- Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50 % of predicted normal；
- Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
- History of stroke or serious thrombotic event within 12 months prior to screening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 4 centers
- Fuxing Hospital — Beijing
- Peking Union Medical College Hospital — Beijing
- Peking University People's Hospital — Beijing
- The First Affiliated Hospital of Harbin Medical University — Harbin
Identifiers
NCT: NCT06697483 · 2024PHB165-001-20240930