Myeloma Clinical Trial
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
Clinically demonstrated efficacy of Melphalan and Prednisone in MM subjects as well as the confirmed inhibitory effect of dasatinib on several tyrosine kinase receptors and pathways implicated in the pathophysiology of MM. Additionally, as a SRC inhibitor, dasatinib plays an important role on bone metabolism through inhibition of osteoclast-mediated bone resorption in vitro. Dasatinib could, thus, be beneficial on bone density of patients on study, through blockage of osteolysis and control of bone lesions.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03832127 -
Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients
|
Phase 1 | |
Completed |
NCT01413178 -
A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
|
Phase 3 | |
Recruiting |
NCT03641456 -
VRD as Induction Followed by VR Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma
|
Phase 2 | |
Completed |
NCT03135925 -
Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation
|
N/A | |
Terminated |
NCT02907073 -
Positron Emission Tomography (PET) Imaging Studies With NIS Reporter
|
Phase 1/Phase 2 | |
Withdrawn |
NCT02114502 -
Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma
|
Phase 2 | |
Completed |
NCT00800839 -
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide
|
Phase 2 | |
Completed |
NCT01700608 -
Prospective Observational Study on Plerixafor After Chemotherapy
|
N/A | |
Completed |
NCT00794261 -
Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma
|
Phase 2 | |
Completed |
NCT00606437 -
Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants
|
Phase 1 | |
Recruiting |
NCT05528887 -
Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies
|
Phase 1 | |
Recruiting |
NCT05625971 -
Non-invasive MRD Assessment in Multiple Myeloma
|
||
Active, not recruiting |
NCT02931942 -
Changing Over Time of Ascorbic Acid After Chemotherapy
|
||
Active, not recruiting |
NCT05889221 -
Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma
|
N/A | |
Recruiting |
NCT03836690 -
Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation
|
Phase 1 | |
Active, not recruiting |
NCT02542657 -
Ixazomib With Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients With Multiple Myeloma
|
Phase 1/Phase 2 | |
Completed |
NCT01279694 -
Trial of Carfilzomib Plus Melphalan and Prednisone in Elderly Untreated Patients With Multiple Myeloma (CARMYSAP)
|
Phase 1/Phase 2 | |
Completed |
NCT01191060 -
Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years
|
Phase 3 | |
Terminated |
NCT00983346 -
Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients
|
Phase 2 | |
Completed |
NCT00476294 -
Long-Term Follow Up Study for AMD3100 Patients
|
N/A |