Study of Lenalidomide and Dexamethasone with or without Pembrolizumab in newly diagnosed and treatment-naïve Multiple Myeloma.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 640

Inclusion Criteria

1.Newly diagnosed, treatment-naïve, ASCT ineligible, symptomatic MM (CRAB features).
2.Confirmed diagnosis of active MM and measurable disease defined as:
-> or = 10% bone marrow plasma cell percentage or biopsy proven bony or extramedullary plasmacytoma and
-Serum monoclonal protein (M-protein) levels > or = 0.5 g/dL or
-Urine monoclonal protein (M-protein) levels > or =200 mg/24-hours or
-Subjects without measurable serum and urine M-protein levels, an abnormal serum free light chain ratio (FLC ?/?) with involved FLC level > or = 100 mg/L. (Normal serum FLC ?/? value: 0.26 - 1.65)
-Presence of CRAB features
3.Must be ineligible to receive treatment with ASCT due to age (> or = 65 years old) or any significant coexisting medical condition (cardiac, renal, pulmonary or hepatic dysfunction), likely to have a negative impact on tolerability of auto-SCT. Subjects < 65 years old who refuse ASCT are not eligible for this study. Note: Sponsor review and approval of participants <65 years old is required before randomization.
4.Provide at screening, archival (< or = 60 days prior to screening date) or newly obtained bone marrow biopsy or aspirate material for disease assessment at the local institutions and MRD characterization for central analysis. Subjects that have agreed to participate in the bone marrow aspirate exploratory sub-study (selected US sites ONLY) should be able to provide a newly obtained bone marrow aspirate for central analysis.
5.Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 480

Exclusion Criteria

1.Has oligo-secretory myeloma, smoldering MM, monoclonal gammopathy of undetermined significance, Waldenström's macroglobulinemia, or any history of plasma cell leukemia.
2.History of repeated infections, primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
3.Has had prior anti-myeloma therapy including but not limited to dexamethasone, IMiDs, proteasome inhibitors, chemotherapy, monoclonal antibody, ASCT or radiation therapy.
4.Has undergone prior allogeneic hematopoetic stem cell transplantation (HSCT) within the last 5 years.
5.Has known hypersensitivity to dexamethasone, lenalidomide, or pembrolizumab.
6.Subjects with peripheral neuropathy > or = Grade 2.
7.Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
8.Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
9.Is unable or unwilling to undergo thromboembolic prophylaxis including, as clinically indicated, aspirin, Coumadin (warfarin) or low-molecular weight heparin.
10.Has lactose intolerance.
11.Has an invasive fungal infection.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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