This Clinical Trials Resource Guide lists six actively recruiting clinical trials that focus on treating multiple myeloma. These studies, ranging from phase I to phase III, are evaluating the safety and efficacy of vaccines, cytotoxic T lymphocytes, and drug treatment regimens. Some studies center on preventing smoldering myeloma from becoming multiple myeloma, whereas others focus on the efficacy of treatment in relation to autologous stem cell transplantation.
More information on all of these trials is available on the National Institutes of Health’s website at ClinicalTrials.gov.
PHASE I
Study Title: Evaluating the Safety and Biological Activity of a Dendritic Cell Survivin Vaccine in Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Cell Transplantation
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
Purpose: To test the safety and efficacy of the Dendritic Cell Survivin Vaccine when administered before and after autologous hematopoietic cell transplantation
Primary Outcome Measures: Rate of complete response [time frame: 90 days post treatment] and number of participants with treatment-emergent adverse events [time frame: up to 6 months post treatment]
Principal Investigator: Frederick Locke, MD, H. Lee Moffitt Cancer Center and Research Institute; contact Dr. Locke at (813) 745-3509 or Frederick.Locke@moffitt.org.
ClinicalTrials.gov Identifier: NCT02851056
Study Title: Administration of Tumor-Associated Antigen–Specific Cytotoxic T Lymphocytes to Patients With Active Myeloma
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Center for Cell and Gene Therapy, Baylor College of Medicine/The Methodist Hospital System
Purpose: To find the largest safe dose of tumor-associated antigen–specific cytotoxic T lymphocytes, the side effects thereof, and its efficacy in treating multiple myeloma
Primary Outcome Measures: Number of patients with adverse events [time frame: 8 weeks]
Principal Investigator: Premal Lulla, MD, Baylor College of Medicine and Houston Methodist Hospital; contact either Dr. Lulla at (832) 824-4847 or lulla@bcm.edu or Wendy Callejas at (832) 824-1538 or wlcalle2@texaschildrens.org.
ClinicalTrials.gov Identifier: NCT02291848
PHASE II
Study Title: Denosumab for Smoldering Multiple Myeloma
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: University of Rochester
Purpose: To assess the safety and tolerability of denosumab in patients with smoldering multiple myeloma, as well as see whether denosumab can reduce the risk of developing multiple myeloma
Primary Outcome Measures: Proportion of patients with a downgraded risk of smoldering multiple myeloma [time frame: 1 year]
Principal Investigator: Brea Lipe, MD, University of Rochester Wilmot Cancer Center; contact Robin Boerman at (585) 273-1507 or Robin_Boerman@URMC.Rochester.edu.
ClinicalTrials.gov Identifier: NCT03839459
Study Title: A Trial Comparing Single-Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High-Dose Therapy Followed by Autologous Stem Cell Reinfusion
Study Type: Interventional/parallel assignment
Study Sponsor and Collaborators: Swedish Medical Center
Purpose: To compare efficacy data between treatment with melphalan and the BEAM regimen
Primary Outcome Measures: Complete response rate [time frame: 12 months]
Principal Investigator: William Bensinger, MD, Swedish Medical Center; contact Neil Bailey, MSc, at neil.bailey@swedish.org; Janell Duey, JD, at (206) 386-2572 or Janell.Duey@swedish.org; or John Kaneko at (206) 386-2370.
ClinicalTrials.gov Identifier: NCT03570983
PHASE III
Study Title: A Randomized, Open-Label Phase III Study of Carfilzomib, Lenalidomide, and Dexamethasone vs Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma (COBRA)
Study Type: Interventional/parallel assignment
Study Sponsor and Collaborators: University of Chicago
Purpose: To compare two treatment regimens (carfilzomib, lenalidomide, and dexamethasone vs bortezomib, lenalidomide, and dexamethasone) for patients with newly diagnosed multiple myeloma
Primary Outcome Measures: Number of participants with progression-free survival in each group after randomization [time frame: 5 years]
Principal Investigator: Andrzej Jakubowiak, MD, University of Chicago; contact Amanda McIver at (773) 834-5884 or amciver@medicine.bsd.uchicago.edu.
ClinicalTrials.gov Identifier: NCT03729804
Study Title: Phase III Randomized Trial of Carfilzomib, Lenalidomide, Dexamethasone vs Lenalidomide Alone After Stem Cell Transplant for Multiple Myeloma
Study Type: Interventional/parallel assignment
Study Sponsor and Collaborators: University of Chicago
Purpose: To compare progression-free survival between carfilzomib, lenalidomide, and dexamethasone vs lenalidomide, as well as the efficacy of the two arms and the rate of minimal residual disease
Primary Outcome Measures: Progression-free survival rate [time frame: 4 years]
Principal Investigator: Andrzej Jakubowiak, MD, PhD, University of Chicago; contact either Jennifer Nam at (773) 702-7716 or jnam@medicine.bsd.uchicago.edu or Abhinav Deol, MD, at (313) 576-8093.
ClinicalTrials.gov Identifier: NCT02659293
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
