Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies the effect of pembrolizumab in treating patients with multiple myeloma that is growing, spreading, or getting worse (progressing) on chimeric antigen receptor (CAR)-T cell therapy. 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.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of pembrolizumab in patients who have received B- cell maturation antigen (BCMA)-directed adoptive cell therapy (ACT) and have clinical evidence of progression. II. To obtain anti-tumor activity (best response rates: objective response rate [ORR], very good partial response, [VGPR], complete response [CR], stringent complete remission [sCR], minimal response disease [MRD] negativity) in patients treated with pembrolizumab. SECONDARY OBJECTIVES: I. To evaluate the expansion of engrafted T cells following pembrolizumab administration in the peripheral blood and within the tumor microenvironment. II. To evaluate the phenotype and function of engrafted T cells following pembrolizumab administration. III. Progression free survival (PFS) and overall survival (OS) among patients progressing after ACT that received pembrolizumab. IV. To determine immunogenicity of the salvage regimen. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05204160
Study type Interventional
Source Emory University
Contact Ajay K Nooka, MD,MPH,FACP
Phone (404) 778-1900
Email [email protected]
Status Recruiting
Phase Phase 2
Start date April 11, 2022
Completion date October 21, 2024

See also
  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
Active, not recruiting 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 (COH04S1) Versus Emergency Use Authorization SARS-COV-2 Vaccine for the Treatment of COVID-19 in Patients With Blood Cancer Phase 2
Recruiting NCT05497804 - Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial Phase 2
Not yet recruiting NCT05511428 - Home Based Daratumumab Administration for Patients With Multiple Myeloma N/A
Recruiting NCT04314401 - National Cancer Institute "Cancer Moonshot Biobank"
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
Recruiting NCT03417284 - Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation Phase 1/Phase 2
Recruiting NCT05142371 - Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors N/A
Recruiting NCT04466475 - Radioimmunotherapy (211At-OKT10-B10) and Chemotherapy (Melphalan) Before Stem Cell Transplantation for the Treatment of Multiple Myeloma Phase 1
Recruiting NCT04566328 - Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial Phase 3
Recruiting 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
Active, not recruiting 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
Active, not recruiting NCT03317899 - Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma Phase 2
Not yet recruiting NCT04876248 - Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Positive After Stem Cell Transplant Phase 2