A phase 3 open-label study to compare the efficacy and safety of pomalidomide plus low-dose dexamethasone to high-dose dexamethasone in refractory or refractory/relapsed multiple myeloma subjects

INTERVENTION: Product Name: Pomalidomide Product Code: CC‐4047 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pomalidomide Current Sponsor code: CC‐4047 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4‐ Product Name: Pomalidomide Product Code: CC‐4047 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pomalidomide Current Sponsor code: CC‐4047 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3‐ Product Name: Pomalidomide Product Code: CC‐4047 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pomalidomide Current Sponsor code: CC‐4047 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ Product Name: Pomalidomide Product Code: CC‐4047 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pomalidomide Current Sponsor code: CC‐4047 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Trade Name: Dexamethason‐Ratiopharm® 4 mg tablets Pharmaceutical Form: Tablet INN or Proposed INN: DEXAMETHASONE CAS Number: 50‐02‐2 Other descriptive name: DEXAMETHASONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4‐ Trade Name: Dexamethasone Tablets BP 2.0mg Pharmaceutical Form: Tablet INN or Proposed INN: DEXAMETHASONE CAS Number: 50‐02‐2 Other descriptive name: DEXAMETHASONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ CONDITION: Refractory Multiple Myeloma (MM) or relapsed and refractory MM. ; MedDRA version: 13.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: The primary objective of the study is to compare the efficacy of POM + LD‐DEX compared with that of HD‐DEX in subjects with refractory MM or relapsed and refractory MM. Primary end point(s): The primary study endpoint is progression‐free survival (PFS). Secondary Objective: The secondary objective of the study is to assess the safety of POM + LD‐DEX to that of HD‐DEX in subjects with refractory MM or relapsed and refractory MM. Timepoint(s) of evaluation of this end point: Time to event SECONDARY OUTCOME: Secondary end point(s): • Safety (type, frequency, and severity of adverse events [AEs], and ; relationship of AEs to study drug or comparator) ; • Overall survival (OS) ; • Response (using the new International Myeloma Working Group ; Uniform [IMWG] response criteria) ; • Objective Response (European Group for Blood and Marrow ; Transplantation [EBMT] criteria) ; • Time to progression (TTP) ; • Time to response ; • Duration of response ; • Clinical benefit responses (Time to increased hemoglobin value, time ; to improvement of bone pain, time to improvement of renal function, ; time to improvement of ECOG performance status) ; • The European Organization for Research and Treatment of Cancer QoL ; Questionnaire for Patients with Multiple Myeloma (EORTC QLQ‐MY20) ; Module, the Cancer QoL Questionnaire for Patients with Cancer (EORTC ; QLQ‐C30) Module, and the descriptive system of the EQ‐5D Timepoint(s) of evaluation of this end point: Time to event INCLUSION CRITERIA: 1. Must be = 18 years at the time of signing the informed consent form. 3. Must be able to adhere to the study visit schedule and other protocol requirements. 5. Subjects must have undergone prior treatment with = 2 treatment lines of anti‐myeloma therapy. Induction therapy followed by ASCT and consolidation/maintenance will be considered as one line. 6. Sub 2. The subject must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. The only exception is if a skeletal survey was performed within 60 days prior to the start of Cycle 1, a new survey will not be required. 4. Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M‐protein = 1.0 g/dL or urine M‐protein = 200 mg/24 hours). However, for subjects with IgA multiple myeloma, a serum M‐protein of = 0.5 g/dL or urine M‐protein = 200 mg/24 hours will be eligible for the study.