Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Afte… (NCT05317416) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
United States854 participantsStarted 2022-03-25
Plain-language summary
The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
* Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
* History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
* Partial Response or better according to IMWG criteria at the time of randomization
* Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
* ECOG performance status ≤1
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
* Not pregnant and willing to use contraception
Exclusion Criteria:
* Plasma cell leukemia
* Amyloidosis, Waldenström's macroglobulinemia
* POEMS syndrome
* Known active CNS involvement or clinical signs of myelomatous meningeal involvement
* Previous MM maintenance treatment
* Prior treatment with BCMA targeted therapy
* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or s…
What they're measuring
1
Progression Free Survival
Timeframe: Assessed for up to approximately 5 years