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New treatment option for Multiple Myeloma
Official title Risk Stratification and MRD-driven Maintenance for MM After ASCT
ClinicalTrials.gov ID: NCT06697483
What this study is testing
What is Daratumumab?
Daratumumab is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous...
- 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%).
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Harbin, Heilongjiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Harbin, Heilongjiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.