PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma
Purpose
To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Condition
- Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Relapsed/refractory multiple myeloma - Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody - Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma) - Adequate bone marrow, hematological, kidney and liver function - Resolved acute effects of any prior therapy to baseline severity - Not pregnant
Exclusion Criteria
- Recent history of other malignancies - History of active autoimmune disorders - Any form of primary immunodeficiency - Active and clinically significant bacterial, fungal, or viral infection - Evidence of active mucosal or internal bleeding - History of severe immune-mediated adverse event with prior immunomodulatory treatment - Major surgery within 4 weeks of study treatment start - Radiation therapy within 2 weeks of study treatment start - History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment - Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry - Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy - Requirement for systemic immune suppressive medication except as permitted in the protocol - Current requirement for chronic blood product support
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PF-06863135 |
BCMA-CD3 bispecific antibody |
|
|
Experimental PF-06863135 + dexamethasone |
BCMA-CD3 bispecific antibody + dexamethasone |
|
|
Experimental PF-06863135 + lenalidomide |
BCMA-CD3 bispecific antibody + lenalidomide |
|
|
Experimental PF-06863135 + pomalidomide |
BCMA-CD3 bispecific antibody + pomalidomide |
|
More Details
- Status
- Completed
- Sponsor
- Pfizer
Study Contact
Detailed Description
Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. This is a two part study; Part 1 will assess the safety and tolerability of increasing dose levels of PF-06863135 and Part 2 will evaluate safety and anti-myeloma activity of PF-06863135 at the RP2Ds determined in Part 1.