PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2023-04-28
• Target enrollment: 0
• Participant gender: All

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 recommended Phase 2 dose.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Antibodies; Antibodies, Bispecific; BB 1101; Dexamethasone; Dexamethasone acetate; Immunoglobulins; Lenalidomide; Pomalidomide; Thalidomide

Criteria

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