Plasma Cell Myeloma Clinical Trial
Official title:
Phase II Study of the Combination of MLN 9708 With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma
This phase II trial studies how well ixazomib citrate and lenalidomide after stem cell transplant work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving ixazomib citrate together with lenalidomide may be effective in treating multiple myeloma.
PRIMARY OBJECTIVES: I. Establish safety and efficacy of oral ixazomib citrate (MLN 9708) and lenalidomide in the maintenance setting post autologous stem cell transplant (ASCT) in myeloma patients. SECONDARY OBJECTIVES: I. Incidence of secondary primary malignancy. II. Evaluate the best response rate (stringent complete response [sCR]/near complete response [nCR]/very good partial response [VGPR]/partial response [PR]). III. Evaluate time to progression. IV. Evaluate time to next therapy. V. Evaluate the tolerability and toxicity. VI. Evaluate M. D. Anderson Symptom Inventory (MDASI)-myeloma symptom evaluation. OUTLINE: Beginning 60-180 days post-transplant, patients receive ixazomib citrate orally (PO) on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
| Completed |
NCT02513186 -
Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation
|
Phase 1 | |
| Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
| Completed |
NCT02880228 -
Pembrolizumab, Lenalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplant
|
Phase 2 | |
| Recruiting |
NCT04782687 -
Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma
|
Phase 2 | |
| Completed |
NCT02514668 -
A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma
|
Phase 1 | |
| Active, not recruiting |
NCT03417284 -
Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05142371 -
Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors
|
N/A | |
| Terminated |
NCT03272633 -
Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies
|
Early Phase 1 | |
| Recruiting |
NCT05031897 -
Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant
|
Phase 2 | |
| Active, not recruiting |
NCT03275285 -
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
|
Phase 3 | |
| Completed |
NCT04100044 -
Exercise Prescription for the Improvement of Quality of Life in Elderly Patients With Multiple Myeloma
|
N/A | |
| Active, not recruiting |
NCT00075478 -
Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
|
Phase 3 | |
| Recruiting |
NCT05561387 -
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
|
Phase 3 | |
| Completed |
NCT03317899 -
Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma
|
Phase 2 | |
| Active, not recruiting |
NCT05511428 -
Home Based Daratumumab Administration for Patients With Multiple Myeloma
|
Early Phase 1 | |
| Completed |
NCT01919619 -
Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies
|
Phase 2 | |
| Terminated |
NCT02353572 -
Melphalan and Bortezomib Prior to Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04537871 -
Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study
|
||
| Active, not recruiting |
NCT00719888 -
Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease
|
Phase 2 |