Study of BMS-986453 in Newly Diagnosed Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BMS-986453.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1b Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Newly Diagnosed Multiple Myeloma
Overview
This is a phase 1b study evaluating if BMS-986453 is safe and effective in treating people who have newly diagnosed multiple myeloma after completing initial therapy (induction) when a stem cell transplant is not intended.
Detailed description
This is an open-label study. The investigators propose to examine if BMS-986453 in people with newly diagnosed multiple myeloma may help control their disease for a prolonged period of time despite one-time treatment and challenge continuous treatment which is otherwise prescribed.
Interventions
- Drug BMS-986453
Will be given as a single dose administered by IV infusion.
Primary outcome measures
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: Baseline up to 5 years]
Secondary outcome measures (10)
- Overall Response Rate (ORR) [Time frame: Baseline up to 5 years]
- Overall Survival (OS) [Time frame: Baseline up to 5 years]
- Progression Free Survival (PFS) [Time frame: Baseline up to 5 years]
- Pharmacokinetics (PK) [Time frame: Baseline up to 2 years]
- Complete response rate [Time frame: Baseline up to 5 years]
- MRD negativity [Time frame: Baseline up to 5 years]
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: Up to 15 years]
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: Up to 15 years]
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: Up to 15 years]
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: Up to 15 years]
Eligibility criteria
Inclusion criteria
- Age > 18 years with no upper age limit
- NDMM with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available.
- Not eligible for ASCT by institutional criteria or deferring ASCT due to personal preference.
- ECOG performance status 0-1
- Adequate organ function
Exclusion criteria
- Known active or history of central nervous system (CNS) involvement of MM.
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS or clinically significant amiloidosis.
- Prior history of other malignancies
- Uncontrolled infection
Other protocol-defined Inclusion/Exclusion criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT07333261 · IRB-300015643 (UAB2595) · 000551303