Multiple Myeloma MedDRA version: 14.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Lenalidomide
Product Code: CC-5013
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: lenalidomide
CAS Number: 191732-72-6
Current Sponsor code: CC-5013
Other descriptive name: 3-(4
Sponsors
Celgene International Sàrl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 g/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 • IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level = 1.0g/dL or urine M-protein level =200mg/24hours 4. Karnofsky performance status = 60%. 5. Able to adhere to the study visit schedule and other protocol requirements. 6. Women of childbearing potential (WCBP) must: a. Have a negative medically supervised pregnancy test prior to start of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices complete and continued sexual abstinence. b. Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy. 7. Male subjects must: a. Agree to use a condom during sexual contact with a WCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy. b. Agree to not donate semen during study drug therapy and for a period after end of study drug therapy. 8. All subjects must: a. Have an understanding that the study drug could have a potential teratogenic risk. b. Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. c. Agree not to share study medication with another person. d. All patients must be counseled about pregnancy precautions and risks of fetal exposure. 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 450
Exclusion criteria
Exclusion criteria: 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 14 days (2 weeks) of randomisation. 5. Plasmapheresis within 28 days (4 weeks) of randomisation. 6. Any of the following laboratory abnormalities: • Absolute neutrophil count (ANC) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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. ;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).;Timepoint(s) of evaluation of this end point: a) Overall Survival (defined as time from randomisation to death due to any cause) will be compared after all subjects have been in the study for at least 5 years or have died or been lost to follow up before 5 years. b) Time to Progression (defined as time from randomisation to the first documentation of progressive disease or death due to progressive disease during the treatment Phase) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): c) Response rate (including complete Response and partial Response) a) Time to response (defined as time from randomisation to the first documented objective response including CR and PR) b) Duration of response (measured from time of initial response to confirmed disease progression) c) Time to the next anti-myeloma therapy d) Safety (type, frequency, severity [NCI CTCAE version 3.0] of adverse events (AEs), and relationship of adverse events to study drug) d)Quality of Life e) Exploratory assessment on cytogenetic abnormalities;Timepoint(s) of evaluation of this end point: See E.5.2 | — |
Countries
Australia, Austria, Belarus, Belgium, Czech Republic, Denmark, France, Georgia, Germany, Greece, Ireland, Israel, Italy, Netherlands, Poland, Russian Federation, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom
Contacts
Public ContactClinicalTrialDisclosure
Celgene Corporation
Outcome results
None listed