A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study to Determine the Efficacy and Safety of Lenalidomide (Revlimid) in Combination with Melphalan and Prednisone Versus Placebo Plus Melphalan and Prednisone in Subjects with Newly Diagnosed Multiple Myeloma Who Are 65 Years of Age or Older
- Conditions
- Multiple MyelomaMedDRA version: 8.1Level: LLTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2006-001865-41-IE
- Lead Sponsor
- Celgene International Sàrl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
1. Must understand and voluntarily sign an informed consent form
2. Age equal to or greater than 65 years at the time of signing the informed consent
3. Newly diagnosed with symptomatic multiple myeloma as defined by the 3 criteria below:
• MM diagnostic criteria (all 3 required)
• Monoclonal plasma cells in the bone marrow =10% and/or presence of a biopsy proven plasmacytoma
• Monoclonal protein present in the serum and/or urine
• Myeloma-related organ dysfunction
AND have measurable disease as defined by the following;
• IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level = 1.0 g/dL or urine M-protein level = 200 mg/24 hours
• IgA multiple myeloma: Serum M-protein level = 0.5 mg/dL or urine M-protein level = 200 mg/24 hours
• IgD multiple myeloma: Serum M-protein level = 0.05 g/dL or urine M-protein level = 200 mg/24 hours
• Light chain multiple myeloma: Serum M-protein level = 1.0 g/dL or urine M-protein level = 200 mg/24 hours
4. Karnofsky performance status = 60%.
5. Able to adhere to the study visit schedule and other protocol requirements.
6. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual intercourse during the time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Previous treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days [4 weeks] of randomisation]).
2. Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds experimental the ability to interpret data from the study.
3. Pregnant or lactating females.
4. Radiotherapy within 28 days (4 weeks) of randomisation.
5. Plasmapheresis within 28 days (4 weeks) of randomisation.
6. Any of the following laboratory abnormalities:
• Absolute neutrophil count (ANC) < 1,500 cells/µL (1.5 x 10.9/L)
• Platelet count < 75,000/µL (75 x 10.9/L) for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count <30,000/mcrL for subjects in whom = 50% of bone marrow nucleated cells are plasma cells
• Haemoglobin < 8.0 g/dL (80 g/L)
• Serum creatinine > 2.5 mg/dL (221 µmol/L)
• Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
7. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for = 3 years. Exceptions include the following:
• Basal cell carcinoma of the skin
• Squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix
• Carcinoma in situ of the breast
• Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
8. Neuropathy of = grade 2 severity.
9. Known HIV positivity or active infectious hepatitis, type A, B or C.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the efficacy of lenalidomide plus melphalan and prednisone (MPR) compared to placebo plus melphalan and prednisone (MP) in subjects with newly diagnosed multiple myeloma (MM) who are 65 years of age or older.<br><br>;Secondary Objective: To assess the safety of MPR compared to placebo plus MP in subjects with newly diagnosed MM who are 65 years of age or older.<br>;Primary end point(s): Progression free survival (defined as time from randomisation to the first documentation of progressive disease based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria, or death due to any cause during the treatment phase).
- Secondary Outcome Measures
Name Time Method