Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572605
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b2 Study of Talquetamab Plus Concomitant Priming Radiotherapy in Multiple Myeloma With Extramedullary Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III 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 andor effective in treating multiple myeloma patients with extramedullary disease
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety and tolerability of single-field palliative extramedullary disease EMD-directed external beam radiotherapy EMD-EBRT in combination with talquetamab as assessed by incidence of adverse events AEs throughout the trial and unexpected toxicities UTs during step-up and cycle 1 Phase 1b II To evaluate the systemic anti-tumor activitypreliminary efficacy of EMD-EBRT in combination with talquetamab as assessed by EMD-modified overall response rate ORR Phase 2
SECONDARY OBJECTIVE
I To additionally evaluate efficacy through International Myeloma Working Group IMWG overall response rate ORR duration of response DOR progression-free survival PFS and overall survival OS
EXPLORATORY OBJECTIVES
I To assess the impact of EMD-EBRT combined with talquetamab on peripheral blood immune cell populations
II To assess the spatial transcriptomic changes in the medullary and extramedullary tumor microenvironment in response to EMD-EBRT combined with talquetamab
OUTLINE
STEP-UP PERIOD Patients undergo EMD-EBRT once daily QD for 5 treatment fractions on weekdays Monday to Friday and receive talquetamab subcutaneously SC starting after the first fraction of EMD-EBRT and continuing every 2-4 days for up to 3 step-up doses in the absence of unacceptable toxicity
SUBSEQUENT TREATMENT Starting 2-7 days after step-up dose 3 patients receive talquetamab SC on days 1 and 15 of each cycle Cycles repeat every 28 days for up to a maximum of 13 total cycles in the absence of disease progression or unacceptable toxicity
Patients also undergo computed tomography CT andor positron emission tomography PETCT and collection of blood samples throughout the trial and undergo image-guided EMD biopsy at screening and on study Patients undergo bone marrow biopsyaspiration at screening and optionally at end of treatment
After completion of study treatment patients are followed up every 28 days for up to 12 months
I To evaluate the safety and tolerability of single-field palliative extramedullary disease EMD-directed external beam radiotherapy EMD-EBRT in combination with talquetamab as assessed by incidence of adverse events AEs throughout the trial and unexpected toxicities UTs during step-up and cycle 1 Phase 1b II To evaluate the systemic anti-tumor activitypreliminary efficacy of EMD-EBRT in combination with talquetamab as assessed by EMD-modified overall response rate ORR Phase 2
SECONDARY OBJECTIVE
I To additionally evaluate efficacy through International Myeloma Working Group IMWG overall response rate ORR duration of response DOR progression-free survival PFS and overall survival OS
EXPLORATORY OBJECTIVES
I To assess the impact of EMD-EBRT combined with talquetamab on peripheral blood immune cell populations
II To assess the spatial transcriptomic changes in the medullary and extramedullary tumor microenvironment in response to EMD-EBRT combined with talquetamab
OUTLINE
STEP-UP PERIOD Patients undergo EMD-EBRT once daily QD for 5 treatment fractions on weekdays Monday to Friday and receive talquetamab subcutaneously SC starting after the first fraction of EMD-EBRT and continuing every 2-4 days for up to 3 step-up doses in the absence of unacceptable toxicity
SUBSEQUENT TREATMENT Starting 2-7 days after step-up dose 3 patients receive talquetamab SC on days 1 and 15 of each cycle Cycles repeat every 28 days for up to a maximum of 13 total cycles in the absence of disease progression or unacceptable toxicity
Patients also undergo computed tomography CT andor positron emission tomography PETCT and collection of blood samples throughout the trial and undergo image-guided EMD biopsy at screening and on study Patients undergo bone marrow biopsyaspiration at screening and optionally at end of treatment
After completion of study treatment patients are followed up every 28 days for up to 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None