A Study of Combination of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pom… (NCT05028348) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Combination of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Subject With Previously Treated Multiple Myeloma
France, Germany117 participantsStarted 2022-04-19
Plain-language summary
This phase 3 randomized, open-label multicenter trial will compare the efficacy, safety and the impact on health-related quality of life (HR-QoL) of SPd versus EloPd in pomalidomide-naïve patients with MM who have received 1 to 4 prior anti-MM regimens and been treated with an immunomodulatory imide drug (IMiD), proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody (mAb).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Relapsed or refractory MM with measurable disease per IMWG guidelines as defined by at least 1 of the following:
✓. Serum M-protein ≥0.5 g/dL (≥5 g/L) by serum protein electrophoresis (SPEP) or, for immunoglobulin (Ig) A or D myeloma, by quantitative serum IgA or IgD levels ≥ 0.5 g/dL.
✓. Serum free light chain (FLC) ≥100 mg/L, provided that the FLC ratio is abnormal (normal FLC ratio: 0.26 to 1.65)
✓. Received at least 1 and no more than 4 prior anti-MM lines of therapy. Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy.
✓. Prior therapy that includes ≥ consecutive cycles of lenalidomide and a proteasome inhibitor given alone or in combination
✓. Prior therapy with an anti-CD38 mAb as part of their immedicate last treatment prior to study entry (Before protocol version2.0, patient with any prior therapy with an anti-CD38 mAb were eligible for the study).
✓. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
Exclusion criteria
✕. Smoldering MM.
✕. Plasma cell leukemia.
✕. Documented active systemic amyloid light chain amyloidosis.
What they're measuring
1
Progression-free survival (PFS)
Timeframe: from randomization to the date of disease progression or death (approximately up to 5 years)