Clinical Trials Logo
  1. Home
  2. Recurrent Plasma Cell Myeloma
  3. NCT03267888

Pembrolizumab and Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma

Recurrent Plasma Cell Myeloma Clinical Trial

Official title:
Pilot Study of Pembrolizumab and Single-Fraction, Low-Dose, Radiation Therapy in Patients With Relapsed or Refractory Multiple Myeloma

Clinical Trial Summary

This pilot clinical trial studies the side effects of pembrolizumab and radiation therapy in treating patients with stage I-III multiple myeloma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as pembrolizumab, may block cancer growth in different ways by targeting certain cells. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving pembrolizumab and radiation therapy may work better in treating patients with stage I-III multiple myeloma.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate the safety of concurrent single/low dose radiation therapy (radiotherapy) (8 Gy/1fx) in combination with pembrolizumab in relapsed or refractory myeloma patients. SECONDARY OBJECTIVES: I. To characterize late toxicity (Common Terminology Criteria for Adverse Events [CTCAE] > grade 2 toxicity at 6 and 12 months) and the effect of radiation in combination with pembrolizumab on systemic response rates using international myeloma working group (IMWG) uniform response criteria for multiple myeloma at 6 months and 12 months. II. To assess changes in positron emission tomography/computed tomography (PET/CT) as a result of combining pembrolizumab and radiotherapy at 6 months and 12 months. OUTLINE: Patients undergo radiation therapy on day 1. Patients also receive pembrolizumab intravenously (IV) over 30 minutes on day 2 or 3. Courses with pembrolizumab repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks thereafter. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03267888
Study type Interventional
Source Emory University
Contact
Status Completed
Phase Phase 1
Start date May 29, 2018
Completion date September 2, 2022
View Details
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
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