elderly untreated patients with multiple myeloma. MedDRA version: 12.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Product Name: Carfilzomib
Product Code: PR-171
Pharmaceutical Form: Concentrate for solution for injection
Trade Name: Alkéran
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MELPHALAN
C
Sponsors
CHU de Nantes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study. 1. Must understand and voluntarily sign an informed consent form 2. Age > 65 years at the time of signing consent 3. Previously untreated, symptomatic multiple myeloma as defined by the 2 criteria below: • MM diagnostic criteria (all 3 required): o Monoclonal plasma cells in the bone marrow =10% and/or presence of a biopsy-proven plasmacytoma o Monoclonal protein present in the serum and/or urine o 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 3 months 7. Affiliation number to National Health Care System 8. Karnofsky performance status (KPS) of at least 60% 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
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following exclusion criteria are not eligible to enroll in this study. 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 consent 2. Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. 3. Any of the following laboratory abnormalities • Absolute neutrophil count (ANC) 3.0× upper limit of normal (ULN); Bilirubin >2× ULN [ALT more specific to liver] • Creatinine clearance = 30 mL/min (Cockcroft-Gault calculation) 4. 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) 5. Peripheral neuropathy of > grade 2 severity. 6. Myocardial infarction within 3 months of enrollment, unstable angina within 2 months or New York Heart Association class III or IV heart failure. 7. Known HIV positivity or active infectious hepatitis, type A, B, or C. 8. Female of childbearing potential 9. Oral or IV fluid hydration contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: The primary objectives of this phase I/II study are to identify the most appropriate dose of Carfilzomib in combination with a standard Melphalan Prednisone (MP) treatment regimen (phase I) and to evaluate the efficacy of Carfilzomib plus MP (CMP) in terms of overall response rate [(ORR), consisting of complete response (CR), very good partial response (VGPR), and partial response (PR) (phase II)].;Secondary Objective: Secondary Objectives: Secondary objectives are to evaluate the safety and tolerability of CMP and to assess efficacy of CMP in terms of clinical benefit response [(CBR = ORR + minimal response (MR)], progression-free survival (PFS), duration of response, and overall survival (OS).;Primary end point(s): identify the most appropriate dose of Carfilzomib in combination with a standard Melphalan Prednisone (MP) treatment regimen and to evaluate the efficacy of Carfilzomib plus MP | — |
Countries
France
Outcome results
None listed