External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease
NCT Number: NCT06572605
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Extramedullary Disease in Multiple Myeloma|Multiple Myeloma
Interventions: PROCEDURE: Biospecimen Collection|PROCEDURE: Bone Marrow Aspiration|PROCEDURE: Bone Marrow Biopsy|PROCEDURE: Computed Tomography|OTHER: Electronic Health Record Review|RADIATION: External Beam Radiation Therapy|PROCEDURE: Image Guided Biopsy|PROCEDURE: Positron Emission Tomography|BIOLOGICAL: Talquetamab
Sponsor: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-15
Completion Date: 2028-06-30
Locations: City of Hope Medical Center, Duarte, California, 91010, United States

Summary:
This phase I/II trial tests the safety and effectiveness of extramedullary disease (EMD)-directed external beam radiation therapy (EBRT) in combination with talquetamab for the treatment of multiple myeloma patients with extramedullary disease. Extramedullary disease in multiple myeloma involves the infiltration of organs and soft tissues by malignant plasma cells and has proven difficult to treat. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink cancers. EBRT is a type of radiation therapy that delivers high-energy beams to the cancer from outside of the body. In this trial, the EBRT will be directed to a site of extramedullary disease. Talquetamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Combining EMD-directed EBRT with talquetamab may be safe, tolerable, and/or effective in treating multiple myeloma patients with extramedullary disease.

Primary Outcome Measures: Incidence of adverse events (phase 1b), Toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome. Toxicity information recorded in each patient will include the type, severity, and the probable association with the study regimen. Tabular and graphical summaries will be used to represent the observed incidence by severity and type of toxicity., From start of protocol therapy until cycle 1 day 28|Extramedullary disease (EMD)-modified overall response rate (ORR) (phase 2), EMD-modified ORR will be defined as the proportion of patients meeting the criteria for partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR). Disease response will be evaluated per International Myeloma Working Group (IMWG) response criteria and Response Criteria for EMD. Clopper-Pearson 95% confidence intervals will be calculated for these estimates., Up to 12 months
Secondary Outcome Measures: Progression-free survival, Will be estimated using the product-limit method of Kaplan and Meier., From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 12 months|Overall survival, Will be estimated using the product-limit method of Kaplan and Meier., From first day of treatment to time of death due to any cause, assessed up to 12 months|Duration of response, Will be evaluated in patients with PR or better. Will be estimated using the product-limit method of Kaplan and Meier., From first response documented until disease progression, assessed up to 12 months|Clinical benefit rate, Clinical benefit rate will be defined as the proportion of patients meeting the criteria for stable disease, PR, VGPR, CR, or sCR. Disease response will be evaluated per IMWG response criteria. Clopper-Pearson 95% confidence intervals will be calculated for these estimates., Up to 12 months|Incidence of adverse events, Will evaluate the frequency and severity of adverse events, severe adverse events, laboratory abnormalities. Toxicity information recorded in each patient will include the type, severity, and the probable association with the study regimen. Tabular and graphical summaries will be used to represent the observed incidence by severity and type of toxicity., Up to 12 months