Patients aged 65 and over, suffering of previously untreated symptomatic multiple myeloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Product Name: LENALIDOMIDE
Product Code: L
Pharmaceutical Form: Capsule*
Product Name: DEXAMETHASONE
Product Code: D
Pharmaceutical Form: Tablet
Product Name: MELPHALAN
Product Code: M
Pharmaceutica
Sponsors
Intergroupe Francophone du Myélome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to participate in this study protocol, patients must fulfill the following conditions: - Must understand and voluntarily sign and informed consent form - Age = 65 years at the time of signing consent - Previously untreated, 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 (at least one of the following) • [C] Calcium elevation in the blood (serum calcium >10.5 mg/l or upper limit of normal) • [R] Renal insufficiency (serum creatinine >2 mg/dl) • [A] Anemia (hemoglobin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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 randomization] - Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study - Any of the following laboratory abnormalities: ? Absolute neutrophil count (ANC) 3.0 x upper limit of normal (ULN) ? Creatinine clearance = 30 mL/min (Cockroft-Gault calculation) - 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 histological finding of prostate cancer (TNM stage of T1a or T1b) - Patients who have are unable or unwilling to undergo antithrombotic therapy - Peripheral neuropathy of > grade 2 severity - Known HIV positivity or active infectious hepatitis, type A, B, or C. - Primary AL amyloidosis and myeloma complicated by amyloidosis. - Renal failure requiring dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This protocol (in patients aged 65 and over suffering from previously untreated multiple myeloma), represents the first worldwide, pharmacogenomic study on this scale in terms of the number of patients analyzed and the implemented molecular diagnostics resources. The goal is to be able to identify patients who will best respond to the study treatments or experience the fewest associated side effects and improve prognosis, in order to optimize care management in multiple myeloma. To this end, the study seeks to predict the following parameters in these patients: • the treatment response and occurrence of adverse events linked to a lenalidomide-dexamethasone combination or a melphalan-prednisone-thalidomide combination. • progression-free survival and overall survival. ;Secondary Objective: ;Primary end point(s): To predict survival, best response and toxicity in newly diagnosed myeloma patients who are either 65 years of age or older treated with either a combination of melphalan-prednisone-thalidomide or lenalidomide-dexamethasone | — |
Countries
Belgium
Outcome results
None listed