Refractory Multiple Myeloma Clinical Trial
Official title:
Phase I/II Study of Combination of Aurora Kinase Inhibitor MLN8237 and Bortezomib in Relapsed or Refractory Multiple Myeloma
RATIONALE: Aurora A kinase inhibitor MLN8237 and bortezomib may stop the growth of cancer
cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving aurora A
kinase inhibitor MLN8237 together with bortezomib and to see how well they work in treating
patients with relapsed or refractory multiple myeloma.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated doses (MTD) with the combination of MLN8237 and
bortezomib. (Phase I) II. To describe the toxicities associated with the combination of
MLN8237 and bortezomib. (Phase I) III. To evaluate the overall response rate to the
combination of MLN8237 and bortezomib in patients with relapsed or refractory multiple
myeloma. (Phase II)
SECONDARY OBJECTIVE:
I. To assess progression-free and overall survival in patients treated with this
combination. (Phase II) OUTLINE: This is a phase I dose escalation study followed by a phase
II study. Patients receive oral aurora kinase inhibitor MLN8237 once daily on days 1-14 and
bortezomib IV on days 1, 4, 8 and 11. Treatment repeats every 28 days for up to 10 courses
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment all patients are followed every 2 months for 1 year and
then every 3 months for 1 year.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04083534 -
First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM)
|
Phase 1/Phase 2 | |
| Completed |
NCT01775553 -
Study of High Dose Carfilzomib in Multiple Myeloma Patients Who Have Progressed On Standard Dose Carfilzomib
|
Phase 2 | |
| Terminated |
NCT02020941 -
Carfilzomib in Treating Patients With Multiple Myeloma in First Relapse or Refractory to First-Line Therapy
|
Phase 2 | |
| Completed |
NCT01212952 -
Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1/Phase 2 | |
| Terminated |
NCT01078441 -
Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant
|
Phase 2 | |
| Completed |
NCT01233921 -
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
|
N/A | |
| Completed |
NCT00514137 -
Sunitinib in Treating Patients With Relapsed Multiple Myeloma
|
Phase 2 | |
| Completed |
NCT00306813 -
Evaluation of Lenalidomide, Doxorubicin and Dexamethasone (RAD) in Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1/Phase 2 | |
| Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
| Completed |
NCT00047203 -
Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 2 | |
| Active, not recruiting |
NCT03731832 -
Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory Multiple Myeloma
|
Phase 2 | |
| Completed |
NCT00003196 -
Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma
|
N/A | |
| Recruiting |
NCT03601624 -
Pomalidomide/Cyclophosphamide/Dexamethasone in Relapse Refractory Myeloma: Safety Profile in Mexicans
|
Phase 2 | |
| Terminated |
NCT01954784 -
Lenalidomide After Donor Stem Cell Transplant and Bortezomib in Treating Patients With High Risk Multiple Myeloma
|
Phase 1 | |
| Recruiting |
NCT05020444 -
TriPRIL CAR T Cells in Multiple Myeloma
|
Phase 1 | |
| Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 | |
| Recruiting |
NCT04302324 -
A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab
|
Phase 2 | |
| Recruiting |
NCT06119685 -
IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
|
Phase 1/Phase 2 | |
| Completed |
NCT00118170 -
Sorafenib in Treating Patients With Metastatic or Unresectable Solid Tumors, Multiple Myeloma, or Non-Hodgkin's Lymphoma With or Without Impaired Liver or Kidney Function
|
Phase 1 | |
| Completed |
NCT00054353 -
Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma
|
Phase 1/Phase 2 |