The purpose of this trial is to determine which dose level of PF-06863135 is safest, best tolerated, and works best when given by itself and combined with pomalidomide or lenalidomide to patients with relapsed/refractory multiple myeloma.
This trial is currently open and accepting patients.
This phase 1 trial is being planned and conducted in two different parts, dose escalation (Part 1) and dose expansion (Part 2). Patients participating in Part 1 will receive different dose levels of PF-06863135. Patients participating in Part 2 will receive the dose of PF-06863135 determined to be safest in Part 1. Other drugs may be given with PF-06863135 depending on when you join the trial.
Patients can continue to participate in the study as long as they don’t develop bad side effects and their myeloma doesn’t get worse.
All patients participating in Part 1 must receive their first dose of PF-06863135 during a hospitalization on days 1-3 of their first cycle. Depending on how patients respond to PF-06863135, and whether they develop side effects, researcher may decide to give a priming dose of PF-06863135, which would be one single dose given in the hospital before you receive other scheduled treatments in the trial.
In this part of the trial, researchers are trying to determine the dose of PF-06863135 that is safest and best tolerated by itself. The dose of PF-06863135 you will receive, and whether you receive any other drugs with it, depends on when you join the trial. Once a certain number of patients have safely received a dose of PF-06863135, researchers may decide to give the next group of patients an increased dose.
Part 1C: PF-06863135 in combination with lenalidomide (Enrollment Temporarily Suspended)
This part of the trial is organized into 28 day cycles, and seeks to enroll approximately 6 patients. Patients will receive PF-06863135 by subcutaneous injection on Day 1, and weekly thereafter. Patients will take lenalidomide by mouth on days 1-21 of each cycle.
Part 1D: PF-06863135 in combination with pomalidomide (Enrollment Temporarily Suspended)
This part of the trial is organized into 28 day cycles, and seeks to enroll approximately 6 patients. Patients will receive PF-06863135 by subcutaneous injection at differing dose levels determined by previous parts of the trial. Patients will receive PF-06863135 on Day 1, and weekly thereafter. Patients will also receive pomalidomide by mouth on days 1-21.
In this part of the trial, researchers will give a larger group of participants the best dose of PF-06863135 determined in Part 1. Patients participating in Part 2 may or may not need to be hospitalized during their first dose of PF-06863135. Depending on how patients respond to PF-06863135, and whether they develop side effects, researcher may decide to give a priming dose of PF-06863135, which would be one single dose given in the hospital before you receive other scheduled treatments in the trial.
Part 2A: PF-06863135 as monotherapy (Currently Accepting Patients)
This part of the trial seeks to enroll approximately 20 patients. Patients will receive PF-06863135 by subcutaneous injection and at a dose level determined by previous parts of the trial.
Enrollment: 80 patients (estimated)View More
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.
December 07, 2020
The primary objectives of this portion of the study were to assess safety and tolerability of PF-06863135 administered subcutaneously, to determine the maximum tolerated dose, and to select the recommended Phase 2 dose. In the study, no dose-limiting toxicities were observed across any of the subcutaneous dose levels evaluated (80 to 1,000 μg/kg weekly) during dose escalation. Cytokine release syndrome (CRS) was reported in 73.3% of patients and was limited exclusively to grade 1 (56.7%) or grade 2 (16.7%). Grade 3 or higher adverse events (AEs) occurring in more than 10% of patients included lymphopenia (53.3%), neutropenia (26.7%), thrombocytopenia (16.7%) and anemia (16.7%).
The overall response rate (ORR) was 80% among the 20 patients treated in cohorts across the efficacious dose range of 215 to 1,000 μg/kg weekly. Among these 20 patients, six achieved stringent complete response or complete response, three achieved very good partial response, and six achieved partial response. Three responding patients had received at least one prior BCMA-targeted therapy. At the highest dose level of 1,000 μg/kg, the ORR was 83% (5/6 patients). Based on these data, 1,000 μg/kg weekly is the recommended Phase 2 dose.
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