Recurrent Plasma Cell Myeloma Clinical Trial
Official title:
Overcoming Chemotherapy Resistance in Refractory Multiple Myeloma With Simvastatin, A Pilot Study
This pilot clinical trial studies how well simvastatin works in overcoming chemotherapy resistance in patients with multiple myeloma that has come back or does not respond to treatment. Simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To examine the effect of simvastatin on myeloma (M)-protein and/or free light chains ratio
when added to conventional chemotherapy for the treatment of multiple myeloma patients who
have received up to 3 (=< 3) and > 3 different chemotherapy regimens. (group A and group B)
SECONDARY OBJECTIVES:
I. To estimate the progression-free survival (PFS), time to progression (TTP), and duration
of response (DOR) in group A, group B, and both groups combined.
II. To describe toxicities (frequency and severity during the treatment) in group A, group B,
and both groups combined.
III. To estimate overall response (OR) in group A, group B, and both groups combined.
IV. To evaluate the quality of life (QoL) of patients on the combined treatment in group A,
group B, and both groups combined.
OUTLINE:
Patients receive standard of care chemotherapy for up to 3 courses and simvastatin orally
(PO) daily 2 days before the first dose of chemotherapy for up to 2 days after the last dose
of chemotherapy. Treatment with simvastatin continues in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 3-5 weeks for
the first 6 months, and every 1-3 months thereafter.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
| Terminated |
NCT04956302 -
Panobinostat in Combination With Daratumumab, Bortezomib and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma
|
Phase 1 | |
| Completed |
NCT01527045 -
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT01689987 -
Hydroxychloroquine, Cyclophosphamide, Dexamethasone, and Sirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
| Completed |
NCT02506959 -
Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma
|
Phase 2 | |
| Active, not recruiting |
NCT03457142 -
Abatacept, Ixazomib Citrate, and Dexamethasone in Treating Patients With Multiple Myeloma Resistant to Chemotherapy
|
Phase 2 | |
| Recruiting |
NCT03246906 -
Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation
|
Phase 2 | |
| Withdrawn |
NCT03328936 -
Study of Personalized Melphalan Dosing in the Setting of Autologous Transplant
|
Phase 2 | |
| Active, not recruiting |
NCT02765854 -
Ixazomib and Dexamethasone Versus Ixazomib, Dexamethasone and Lenalidomide, Randomized With NFKB2 Rearrangement
|
Phase 2 | |
| Recruiting |
NCT05514990 -
Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial
|
Phase 1/Phase 2 | |
| Completed |
NCT01989598 -
Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 2 | |
| Completed |
NCT03605719 -
Dexamethasone, Carfilzomib, & Nivolumab With Pelareorep for Relapsed/Refractory Multiple Myeloma
|
Phase 1 | |
| Completed |
NCT01903811 -
S1304, Carfilzomib and Dexamethasone for Treating Patients With Relapsed or Refractory Myeloma
|
Phase 2 | |
| Recruiting |
NCT05391750 -
Venetoclax and Tocilizumab for the Treatment of Patients With Relapsed or Refractory t(11;14) Multiple Myeloma
|
Phase 1 | |
| Completed |
NCT00789776 -
Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Hematologic Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02593123 -
Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis
|
Phase 2 | |
| Terminated |
NCT04407442 -
Daratumumab, Azacitidine, and Dexamethasone for Treatment of Patients With Recurrent or Refractory Multiple Myeloma Previously Treated With Daratumumab
|
Phase 2 | |
| Completed |
NCT00450814 -
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma
|
Phase 1/Phase 2 | |
| Completed |
NCT03338972 -
Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
| Recruiting |
NCT04508790 -
Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
|
Phase 2 |