NCT07333261 · Susan Bal
Study of BMS-986453 in Newly Diagnosed Multiple Myeloma
What this study is about
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.
View original scientific description
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.
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
Evaluate the safety and tolerability of BMS-986453 in participants with NDMM.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Birmingham, Alabama
Collaborators
Bristol-Myers Squibb
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 13, 2026 · Source of record for eligibility and locations