Status:
COMPLETED
PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma
Lead Sponsor:
Pfizer
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 rec...
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 myelo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2024
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT03269136
Start Date
November 29 2017
End Date
January 19 2024
Last Update
March 18 2025
Active Locations (37)
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1
UCSD Medical Center - Encinitas
Encinitas, California, United States, 92024
2
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)
La Jolla, California, United States, 92037
3
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037
4
UC San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103