Myeloma Clinical Trial
Official title:
Phase II Study of Simvastatin, Zoledronic Acid, Bortezomib, Bendamustine and Methylprednisolone for Relapsed/Refractory Myeloma
The purpose of this study test the hypothesis that the combination of simvastatin and zoledronic acid (for reversal of drug resistance), with bortezomib, high-dose methylprednisolone and bendamustine on a day 1,8 schedule (to reduce toxicity) will be an effective and well-tolerated treatment for relapsed and refractory multiple myeloma
OBJECTIVES
Primary To estimate the overall response rate (ORR) (complete response (CR) + very good
partial response (VGPR) + partial response (PR)) of patients with multiple myeloma who have
relapsed or are refractory after bortezomib treatment and will now receive a combination
therapy of simvastatin, zoledronic acid, bortezomib, bendamustine and methylprednisolone.
To evaluate safety and tolerability of studied therapy.
Secondary
1. To estimate the progression-free Survival (PFS), time to progression (TTP), overall
survival (OS) and duration of response (DOR).
2. To describe toxicities (frequency and severity) during the treatment. 3 To estimate
clinical benefit response (CBR) (ORR + minor response (MR)) and stable disease (SD).
4 Explore factors associated with ORR, PFS, OS, toxicity.
;
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 | |
Terminated |
NCT02907073 -
Positron Emission Tomography (PET) Imaging Studies With NIS Reporter
|
Phase 1/Phase 2 | |
Completed |
NCT03135925 -
Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation
|
N/A | |
Withdrawn |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 |
NCT00794261 -
Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma
|
Phase 2 | |
Completed |
NCT01700608 -
Prospective Observational Study on Plerixafor After Chemotherapy
|
N/A | |
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 |
NCT01191060 -
Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years
|
Phase 3 | |
Completed |
NCT01279694 -
Trial of Carfilzomib Plus Melphalan and Prednisone in Elderly Untreated Patients With Multiple Myeloma (CARMYSAP)
|
Phase 1/Phase 2 | |
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 |