Study of Lenalidomide and Dexamethasone with or without Pembrolizumab in Newly Diagnosed and Treatment-Naïve Multiple Myeloma.

Phase 1

• Conditions: ewly diagnosed, treatment-naïve multiple myeloma (MM) who are ineligible for autologous stem cell transplant (auto-SCT).; MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002901-12-IT
• Lead Sponsor: MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-08
• Last Update Posted: 12 February 2018

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:
a. Serum monoclonal protein (M-protein) levels = 0.5 g/dL or
b. Urine monoclonal protein (M-protein) levels =200 mg/24-hours or
c. 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)
d. Presence of CRAB features
3. Must be ineligible to receive treatment with ASCT due to age (=65 years old) or coexisting medical condition. Subjects < 65 years old who refuse ASCT are not eligible for this study.
4. Provide, archival (=60 days) or newly obtained bone marrow biopsy or aspirate material for disease assessment and biomarker 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: 1
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. Subjects with non-secretory or oligo-secretory myeloma, smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), plasma cell leukemia or Waldenström's macroglobulinemia.
2. History of repeated infections, primary amyloidosis, hyperviscosity or POEMS syndrome.
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.
6. Subjects with peripheral neuropathy = Grade 2.
7. Has evidence of active, non-infectious 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified