Dasatinib in Combination With Melphalan and Prednisone to Treat Relapsed and Refractory Multiple Myeloma Patients (D-MP)
|ClinicalTrials.gov Identifier: NCT01116128|
Recruitment Status : Terminated (difficulty in enrolling patients)
First Posted : May 4, 2010
Last Update Posted : June 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Myeloma||Drug: dasatinib Drug: melphalan Drug: prednisone||Phase 2|
Primary Objective: To determine whether the combination of dasatinib with melphalan and prednisone provides therapeutic benefits and is safe in patients with relapsed/refractory Multiple Myeloma.
Study design, dose and mode of administration, and duration of treatment: Multicenter, open-label, single arm, two-stage, Phase II study of dasatinib in combination with melphalan and prednisone (D-MP) in advanced, refractory MM patients. The three drugs will be concurrently administered through 6 cycles; each cycle will be 28 days long (1 cycle = 4 weeks), for a total of 24 weeks of treatment. The treatment schedule will be the following:
- Melphalan 0,18 mg/Kg/day from day 1 to day 4 for 6 cycles;
- Prednisone 1,5 mg/Kg/day from day 1 to day 4 for 6 cycles;
- Dasatinib 100 mg QD continuously (from day 1 to day 28). After the 6 cycles of D-MP treatment, Dasatinib will be continuously administered alone as maintenance, until occurrence of progressive disease, unacceptable toxicity or informed consent withdrawal.
This is a two-stage Phase II trial according to Simon with a bivariate endpoint design, by which treatment efficacy and safety are jointly evaluated. This design allows the trial to be early stopped after the first stage if the number of observed partial responses (PR) is inadequate and the number of observed toxicities is too high. In the first stage of the protocol 17 patients are required.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Phase Ii Study of Dasatinib in Combination With Melphalan and Prednisone (D-MP) in Advanced, Relapsed / Refractory Multiple Myeloma Patients|
|Study Start Date :||February 2008|
|Primary Completion Date :||May 2011|
|Study Completion Date :||May 2011|
U.S. FDA Resources
100 mg QD continuously (from day 1 to day 28)Drug: melphalan
0,18 mg/Kg/day from day 1 to day 4 for 6 cyclesDrug: prednisone
1,5 mg/Kg/day from day 1 to day 4 for 6 cycles
- Partial response rate is a primary study endpoint. [ Time Frame: 4 years ]
Evaluation of tumor status will be conducted at screening and anti-tumor treatment efficacy will be assessed at every cycle according to the International Uniform Criteria for Response in MM.
Safety and tolerability are a co-primary endpoint: incidence of grade 3-4 toxicities will support the decision to move to stage 2, together with PR rate once all the patients accrued to the first stage are evaluable.
- Secondary objectives are progression-free survival and overall survival [ Time Frame: 4 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116128
|Torino, Italy, 10126|
|Principal Investigator:||Mario Boccadoro, MD||Divisione Universitaria di Ematologia Ospedale Molinette di Torino|