Clinical Trials Logo

Clinical Trial Summary

This phase I/II trial studies the safety of the combination of bortezomib, dexamethasone, and pembrolizumab with or without pelareorep in treating patients with multiple myeloma that has come back (relapsed) or does not response to treatment (refractory). Chemotherapy drugs, such as bortezomib and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. A virus modified in the laboratory, such as pelareorep, may be able to kill cancer cells without damaging normal cells. Giving the combination of bortezomib, dexamethasone, and pembrolizumab with pelareorep may work better in treating patient with multiple myeloma.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To establish the safety of bortezomib-dexamethasone (BOR-D) and pembrolizumab (cohort 1) and its combination with pelareorep (PELA) (cohorts 2). (Phase 1B) II. To determine the recommended phase 2 dose (RP2D) for PELA in combination with BOR-D and pembrolizumab in patients with relapsed or refractory multiple myeloma (RRMM; cohorts 2). (Phase 1B) III. To estimate the efficacy of the combination of PELA, BOR -D and pembrolizumab in patients with RRMM. (Phase 2) SECONDARY OBJECTIVES: I. To evaluate the efficacy PELA in combination with BOR-D and pembrolizumab (cohorts 2) in patients with RRMM. (Phase 1B) II. To characterize the safety and tolerability of the combination, including acute and chronic toxicities. (Phase 2) EXPLORATORY OBJECTIVES: I. To compare changes in the tumor microenvironment (TME) and immune responses in patients treated with BOR-D and pembrolizumab (cohort 1) to patients treated with PELA, BOR-D, and pembrolizumab (cohort 2). (Phase 1B) II. To evaluate changes in the TME and immune responses in patients treated with the combination of PELA, BOR-D and pembrolizumab. (Phase 2) OUTLINE: This is a phase IB dose escalation study followed by a phase II study. Patients are assigned to 1 of 2 cohorts. COHORT I: Patients receive bortezomib subcutaneously (SC) or intravenously (IV) and dexamethasone orally (PO), IV, or intramuscularly (IM) on days 1, 8, and 15 of each cycle. Patients also receive pembrolizumab IV over 30 minutes on day 9 of each cycle. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. COHORT II: Patients receive bortezomib SC or IV and dexamethasone either PO, IV, or IM on days 1, 8, and 15 of each cycle. Patients also receive pelareorep IV over 60 minutes on days 1, 2, 8, 9, 15, and 16 and pembrolizumab IV over 30 minutes on day 9 of each cycle. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. After completion of study, patients are followed-up every 12 weeks or every 6 months depending on status of disease. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05514990
Study type Interventional
Source University of Southern California
Contact Christine Duran
Phone 323-865-0371
Email Duran_C@med.usc.edu
Status Recruiting
Phase Phase 1/Phase 2
Start date October 7, 2022
Completion date October 7, 2026

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