Clinical Trials Logo

Clinical Trial Summary

This phase I trial finds out the best dose and side effects of venetoclax and tocilizumab in treating patients with t(11;14) multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Tocilizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Tocilizumab is used to treat side effects from immune therapy in patients with myeloma. Giving venetoclax and tocilizumab may kill more cancer cells.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine the dose limiting toxicity (DLT), safety profile, and the recommended phase 2 dose (RPTD) of venetoclax and tocilizumab when administered in subjects with relapsed and recurrent (RR) multiple myeloma t(11;14) (MM). SECONDARY OBJECTIVES: I.To evaluate the preliminary efficacy data regarding the effect of venetoclax and tocilizumab by objective response rate per IMWG criteria. II. To evaluate the effect of chronic tocilizumab administration on venetoclax exposure. TERTIARY/EXPLORATORY OBJECTIVES: I. To evaluate the preliminary efficacy data regarding the effect of venetoclax and tocilizumab by time to response (TTR), time to disease progression (TTP), duration of response (DOR), progression free survival (PFS) and overall survival (OS). II. To measure the effect of IL6 receptor blockade on ex vivo venetoclax sensitivity. III. To evaluate the cell populations in the bone marrow of responders versus non-responders as well as the effect of IL6 receptor blockade on those populations. IV. To evaluate the expression of B cell markers on venetoclax sensitive myeloma. V. To determine the expression of key BCL2 family members with and without IL6 receptor blockade. VI. To correlate differences in somatic mutations, structural alterations, gene expression and chromatin accessibility with venetoclax response. OUTLINE: This is a dose-escalation study of venetoclax and tocilizumab. Patients receive tocilizumab intravenously (IV) on day -7 of cycle 1, and on day 1 of subsequent cycles. Patients also receive venetoclax orally (PO) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks, then every 6 months thereafter. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05391750
Study type Interventional
Source Emory University
Contact Jonathan L. Kaufman, MD
Phone 404-778-1900
Email jlkaufm@emory.edu
Status Recruiting
Phase Phase 1
Start date October 19, 2022
Completion date February 12, 2027

See also
  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
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
Recruiting NCT05363111 - Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma Phase 1