Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

IFM 2012-03 protocol is a Phase 2 multicenter nonrandomized open in elderly patients with multiple myeloma at diagnosis. Study primary objectives are in the first step to determine Maximum tolerated dose (MTD) of Carfilzomib Weekly based on definition of Dose-limiting toxicities (DLTs) and in the second step to expanded cohort, to determine the VGPR (Very Good Partial Response) + CR (Complete Response) rate of Carfilzomib Weekly at the MTD in combination with Melphalan Prednisone at the end of the 9 induction cycles.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Collaborator: Amgen
• Treatments: Melphalan; Prednisone

Criteria

Inclusion Criteria:

• able to understand and voluntarily sign an informed consent form

• able to adhere to the study visit schedule and other protocol requirements.

• age ≥ 65 years.

• life expectancy > 6 months.Patients must have Symptomatic Measurable previously Untreated MM

• have measurable disease as defined by the following: quantifiable monoclonal M-component value in the serum and/or urine

• eastern Cooperative Oncology Group performance status score ≤2

• dequate bone marrow function, documented within 72 hours and without transfusion 5 days prior to the first intake of investigational product no growth factor support Adequate organ function

• subjects affiliated with an appropriate social security system.

• male subjects must:Understand the potential teratogenic,and genotoxic risk of Melphalan if engaged in sexual activity with a pregnant female or a female of childbearing potential.

• understand the potential genotoxic risk of Carfilzomib if engaged in sexual activity with a pregnant female or a female of childbearing potential.

• practice complete abstinence or understand the need and agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential throughout the entire duration of study treatment, during dose interruptions and until at least 3 months after the end of treatment discontinuation of CMP, even if he has undergone a successful vasectomy.

• if pregnancy or a positive pregnancy test does occur in the partner of a male study patient during study participation, the investigator must be notified immediately.

• agree not to donate semen or sperm during study drug therapy and until at least 3 months after the end of treatment discontinuation of CMP.

Exclusion Criteria:

• any other uncontrolled medical condition or comorbidity that might interfere with subject's participation.

• known positive for HIV or active infectious hepatitis, type B or C.

• patient with terminal renal failure that require dialysis and clearance creatinine < 30 ml/min.

• prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for ≥ 5 years.

• prior local irradiation within two weeks before first dose

• evidence of central nervous system (CNS) involvement.

• unable to take corticotherapy at study entry

• any ongoing adverse event or medical history > grade 2 severity

• persons protected by a legal regime (guardianship, trusteeship).Alkeran's (Melphalan) contraindication: Hypersensitivity to Melphalan or to any other constituents.

• patients with heart failure class 3 and 4 according to the NYHA criteria, or patients with past history of myocardial infarction within the last 6 months or no controlled cardiac conduction abnormalities.

• patients with a left ventricular ejection fraction under or equal to 45 % (LVEF ≤ 45%)