Newly diagnosed, treatment-naïve multiple myeloma (MM) who are ineligible for autologous stem cell transplant (auto-SCT). MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 = 0.5 g/dL or -Urine monoclonal protein (M-protein) levels =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 =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 (=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) yes F.1.3.1 Number of subjects for this age range 480
Exclusion criteria
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 lowmolecular weight heparin. 10.Has lactose intolerance. 11.Has an invasive fungal infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the Progression Free Survival (PFS) as assessed by independent central review according to the International Myeloma Working Group response criteria, (IMWG criteria) between treatment arms.;Secondary Objective: 1.Compare the Overall Survival (OS). 2. Evaluate Overall Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR), as assessed by CAC blinded central Review using IMWG criteria [1], and second Progression Free Survival (PFS2) by investigator assessment, between treatment arms. 3.Compare the Progression Free Survival (PFS) and second Progression Free Survival (PFS2) as assessed by the investigator using IMWG criteria between treatment arms. 4.To evaluate the safety and tolerability in both treatment arms. ;Primary end point(s): The primary end point of the study is Progression-free survival (PFS) – the International Myeloma Working Group response criteria (IMWG 2011) by blinded central review. PFS is defined as the time from randomization to the first documented disease progression per IMWG 2006 based on blinded central review or death due to any cause, whichever occurs first. ;Timepoint(s) of evaluation of this end point: 1.Interim PFS Analysis: ~ 20 months after trial starts (when all subjects enrolled and ~ 115 PFS events are observed). 2.Final PFS Analysis: ~ 20 months after interim PFS analysis and ~227 PFS events are observed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Overall Survival (OS): OS is defined as the time from randomization to death due to any cause. 2.Overall Response Rate (ORR): ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). 3.Duration of Response (DOR): For subjects who demonstrated CR or PR, response duration is defined as the time from first documented evidence of CR or PR until disease progression or death. 4.Second Progression Free Survival (PFS2): PFS2 is the time from randomization to subsequent disease progression after initiation of new anti-cancer therapy, or death from any cause, whichever comes first, by investigator assessment.;Timepoint(s) of evaluation of this end point: ~ 41 months after trial starts (when last subject completes its last phone call follow-up). | — |
Countries
Australia, Brazil, Canada, France, Germany, Ireland, Israel, Italy, Japan, Norway, Russian Federation, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed