Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multip… (NCT02302495) | Clinical Trial Compass
CompletedPhase 2
Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma
France32 participantsStarted 2014-01-08
Plain-language 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.
Who can participate
Age range65 Years
SexALL
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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 …