Multiple Myeloma (MM)
Conditions
Keywords
multiple myeloma, cemsidomide, CFT7455, elranatamab, PF-06863135, relapsed, refractory, RRMM, BCMA, bispecific antibody, BiTE, TCE, ELREXFIO
Brief summary
The main purpose of the study is to understand the safety and tolerability of cemsidomide when given along with elranatamab in subjects with relapsed or refractory multiple myeloma. The first part of the study will evaluate different dose levels of cemsidomide in combination with elranatamab in a limited number of subjects. Approximately 3 different dose levels of cemsidomide in combination with elranatamab may be explored. Once a dose level is determined safe, additional subjects may be enrolled through expansion of the dose level. This expansion will provide further exploration of the safety and evaluation of preliminary antimyeloma activity. Cemsidomide will be taken orally each cycle for 14 days on/14 days off (1 cycle=28 days). Elranatamab will be administered by subcutaneous injection twice a month. Dexamethasone will be administered weekly until a confirmed response but no longer than 4 cycles.
Interventions
DRUGCemsidomide
IKZF1/3 degrader
BIOLOGICALElranatamab
• BCMA-CD3 bispecific antibody
Sponsors
C4 Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of multiple myeloma as defined by IMWG criteria * Measurable disease based on IMWG criteria * Received 2-4 prior lines of therapy (escalation part) and 1-3 prior lines of therapy (expansion part) for multiple myeloma, consisting of at least 1 immunomodulatory drug (i.e., IKZF 1/3 degrader) * ECOG performance status 0-2
Exclusion criteria
* Active plasma cell leukemia, Smoldering multiple myeloma, POEMS Syndrome, systemic light chain amyloidosis, MDS * Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease * Participants with any active, uncontrolled bacterial, fungal, or viral infection * Prior treatment with a BCMA-directed TCE or BCMA-directed CAR-T therapy * Administration with an investigational product within 30 days preceding the first dose of study intervention * Inability or difficulty swallowing tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of cemsidomide in combination with elranatamab | Cycle 1 approximately 28 days | Dose limiting toxicity rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the PK of cemsidomide and elranatamab | Approximately 4 months | Pre and post dose concentrations of cemsidomide |
| Assess the immunogenicity of elranatamab | Approximately 2 years | Percent of participants with positive anti-drug antibodies to elranatamab |
| Assess antimyeloma activity | Approximately 2 years | Objective Response Rate (ORR) per IMWG criteria |
Countries
United States
Contacts
CONTACTStudy Medical Officer
Outcome results
None listed