Back to resultsPF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-06863135 monotherapy IV or SC
PF-06863135 + dexamethasone
PF-06863135 + lenalidomide
PF-06863135 + pomalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, relapse/ refractory multiple myeloma, bispecific antibody, bispecific, BCMA, BCMA- CD3 bispecific, Phase 1, PF-06863135, dexamethasone, lenalidomide, pomalidomide
Eligibility 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
Sites / Locations
- UCSD Medical Center - Encinitas
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)
- UC San Diego Moores Cancer Center
- UC San Diego Medical Center - Hillcrest
- UCSD Medical Center - Vista
- Blood and Marrow Transplant Group of Georgia
- Northside Hospital
- UChicago Medicine - River East
- The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy
- University of Chicago Medical Center
- UChicago Medicine at Ingalls - Flossmoor
- UChicago Medicine Ingalls Memorial
- University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
- The University of Chicago Medicine Center for Advanced Care Orland Park
- UChicago Medicine at Ingalls - Tinley Park
- University of Iowa Hospitals and Clinics
- Ochsner Clinic Foundation
- Massachusetts General Hospital
- Memorial Sloan Kettering Cancer Center at Basking Ridge
- Memorial Sloan Kettering Cancer Center at Monmouth
- Memorial Sloan Kettering Cancer Center at Bergen
- Memorial Sloan Kettering Cancer Center at Commack
- Memorial Sloan Kettering Cancer Center at Westchester
- Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan Kettering Cancer Center at Nassau
- Duke University Health System: Adult Bone Marrow Transplant Clinic
- Duke Cancer Center
- Duke University Hospital
- Henry Joyce Cancer Center
- Baylor University Medical Center
- Investigational Drug Services, Baylor University Medical Center
- Unit 57, Special Services Building
- Tom Baker Cancer Centre
- Cross Cancer Institute
- University Health Network - Princess Margaret Cancer Centre
- McGill University Health center
- MUHC, GLEN site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
PF-06863135
PF-06863135 + dexamethasone
PF-06863135 + lenalidomide
PF-06863135 + pomalidomide
Arm Description
BCMA-CD3 bispecific antibody
BCMA-CD3 bispecific antibody + dexamethasone
BCMA-CD3 bispecific antibody + lenalidomide
BCMA-CD3 bispecific antibody + pomalidomide
Outcomes
Primary Outcome Measures
Dose Escalation: Number of participants with Dose-limiting toxicities (DLT)
Number of participants with DLTs
To evaluate anti-myeloma activity by objective response rate (ORR) in dose expansion
Percentage of participants with Objective Response Rate (ORR) using the international myeloma working group (IMWG) response criteria for multiple myeloma
To evaluate anti-myeloma activity by duration of response (DOR) in dose expansion
Time from first assessment of partial response or better to last assessment of partial response or better by IMWG criteria
Secondary Outcome Measures
To evaluate incidence of treatment emergent adverse events and laboratory abnormalities
Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities
To evaluate anti-myeloma activity by objective response rate (ORR) in dose escalation
Percentage of participants with Objective Response Rate (ORR) using the international myeloma working group (IMWG) response criteria for multiple myeloma
To evaluate anti-myeloma activity by time to event endpoints
Time from start date to date of first documentation of event (response or progression by IMWG criteria or death)
To evaluate anti-myeloma activity by duration of event endpoints
Time from first assessment of event endpoint (response or stable disease) to last assessment of (response or stable disease) by IMWG criteria
Impact of treatment on systemic soluble immune factors
Pre and post dose quantification of soluble cytokines in serum.
Maximum plasma concentration (Cmax) of PF-06863135
Peak concentration of PF-06863135 during first cycle
Trough serum concentrations of PF-06863135 and dexamethasone
Trough serum concentrations of PF-06863135 and dexamethasone at selected cycles
Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135
AUC of PF-06863135 will be calculated at selected cycles
Incidence and titers of anti-drug antibodies and neutralizing antibodies against PF-06863135
Number of participants with the presence of anti-PF-06863135 antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03269136
Brief Title
PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma
Official Title
MAGNETISMM-1 A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH IMMUNOMODULATORY AGENTS IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
December 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 recommended Phase 2 dose.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, relapse/ refractory multiple myeloma, bispecific antibody, bispecific, BCMA, BCMA- CD3 bispecific, Phase 1, PF-06863135, dexamethasone, lenalidomide, pomalidomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-06863135
Arm Type
Experimental
Arm Description
BCMA-CD3 bispecific antibody
Arm Title
PF-06863135 + dexamethasone
Arm Type
Experimental
Arm Description
BCMA-CD3 bispecific antibody + dexamethasone
Arm Title
PF-06863135 + lenalidomide
Arm Type
Experimental
Arm Description
BCMA-CD3 bispecific antibody + lenalidomide
Arm Title
PF-06863135 + pomalidomide
Arm Type
Experimental
Arm Description
BCMA-CD3 bispecific antibody + pomalidomide
Intervention Type
Drug
Intervention Name(s)
PF-06863135 monotherapy IV or SC
Other Intervention Name(s)
BCMA-CD3 bispecific antibody
Intervention Description
PF-06863135 will be administered intravenously or subcutaneously.
Intervention Type
Drug
Intervention Name(s)
PF-06863135 + dexamethasone
Other Intervention Name(s)
BCMA-CD3 bispecific antibody + dexamethasone
Intervention Description
PF-06863135 will be administered intravenously or subcutaneously and dexamethasone orally.
Intervention Type
Drug
Intervention Name(s)
PF-06863135 + lenalidomide
Other Intervention Name(s)
BCMA-CD3 bispecific antibody + lenalidomide
Intervention Description
PF-06863135 will be administered intravenously or subcutaneously and lenalidomide orally
Intervention Type
Drug
Intervention Name(s)
PF-06863135 + pomalidomide
Other Intervention Name(s)
BCMA-CD3 bispecific antibody + pomalidomide
Intervention Description
PF-06863135 will be administered intravenously or subcutaneously and pomalidomide orally
Primary Outcome Measure Information:
Title
Dose Escalation: Number of participants with Dose-limiting toxicities (DLT)
Description
Number of participants with DLTs
Time Frame
At the end of Cycle 1 (each Cycle is 21 or 28 days)
Title
To evaluate anti-myeloma activity by objective response rate (ORR) in dose expansion
Description
Percentage of participants with Objective Response Rate (ORR) using the international myeloma working group (IMWG) response criteria for multiple myeloma
Time Frame
From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Title
To evaluate anti-myeloma activity by duration of response (DOR) in dose expansion
Description
Time from first assessment of partial response or better to last assessment of partial response or better by IMWG criteria
Time Frame
From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Secondary Outcome Measure Information:
Title
To evaluate incidence of treatment emergent adverse events and laboratory abnormalities
Description
Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities
Time Frame
From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Title
To evaluate anti-myeloma activity by objective response rate (ORR) in dose escalation
Description
Percentage of participants with Objective Response Rate (ORR) using the international myeloma working group (IMWG) response criteria for multiple myeloma
Time Frame
From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Title
To evaluate anti-myeloma activity by time to event endpoints
Description
Time from start date to date of first documentation of event (response or progression by IMWG criteria or death)
Time Frame
From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Title
To evaluate anti-myeloma activity by duration of event endpoints
Description
Time from first assessment of event endpoint (response or stable disease) to last assessment of (response or stable disease) by IMWG criteria
Time Frame
From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Title
Impact of treatment on systemic soluble immune factors
Description
Pre and post dose quantification of soluble cytokines in serum.
Time Frame
9 months on treatment
Title
Maximum plasma concentration (Cmax) of PF-06863135
Description
Peak concentration of PF-06863135 during first cycle
Time Frame
Cycle 1 Day 1 and Cycle 2 Day 1 (3 to 4 weeks)
Title
Trough serum concentrations of PF-06863135 and dexamethasone
Description
Trough serum concentrations of PF-06863135 and dexamethasone at selected cycles
Time Frame
From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Title
Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135
Description
AUC of PF-06863135 will be calculated at selected cycles
Time Frame
From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Title
Incidence and titers of anti-drug antibodies and neutralizing antibodies against PF-06863135
Description
Number of participants with the presence of anti-PF-06863135 antibodies
Time Frame
From baseline and scheduled timepoints post dose through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Medical Center - Encinitas
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC San Diego Medical Center - Hillcrest
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSD Medical Center - Vista
City
Vista
State/Province
California
ZIP/Postal Code
92081
Country
United States
Facility Name
Blood and Marrow Transplant Group of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
UChicago Medicine - River East
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
UChicago Medicine at Ingalls - Flossmoor
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
UChicago Medicine Ingalls Memorial
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Facility Name
The University of Chicago Medicine Center for Advanced Care Orland Park
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60462
Country
United States
Facility Name
UChicago Medicine at Ingalls - Tinley Park
City
Tinley Park
State/Province
Illinois
ZIP/Postal Code
60477
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center at Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center at Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center at Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center at Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center at Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
Duke University Health System: Adult Bone Marrow Transplant Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Henry Joyce Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Investigational Drug Services, Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Unit 57, Special Services Building
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
University Health Network - Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
McGill University Health center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
MUHC, GLEN site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C1071001
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma
We'll reach out to this number within 24 hrs