Clinical Trials Logo
  1. Home
  2. Multiple Myeloma
  3. NCT03269136
  4. Details
NCT03269136 Clinical Trial

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

Multiple Myeloma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03269136
Other study ID # C1071001
Secondary ID 2019-000822-24
Status Completed
Phase Phase 1
First received
Last updated
Start date November 29, 2017
Est. completion date January 19, 2024

Study information
Verified date February 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date January 19, 2024
Est. primary completion date January 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• PF-06863135 monotherapy IV or SC
PF-06863135 will be administered intravenously or subcutaneously.
• PF-06863135 + dexamethasone
PF-06863135 will be administered intravenously or subcutaneously and dexamethasone orally.
• PF-06863135 + lenalidomide
PF-06863135 will be administered intravenously or subcutaneously and lenalidomide orally
• PF-06863135 + pomalidomide
PF-06863135 will be administered intravenously or subcutaneously and pomalidomide orally

Locations
Country Name City State
Canada Tom Baker Cancer Centre Calgary Alberta
Canada Unit 57, Special Services Building Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada McGill University Health center Montreal Quebec
Canada MUHC, GLEN site Montreal Quebec
Canada University Health Network - Princess Margaret Cancer Centre Toronto Ontario
United States Blood and Marrow Transplant Group of Georgia Atlanta Georgia
United States Northside Hospital Atlanta Georgia
United States Memorial Sloan Kettering Cancer Center at Basking Ridge Basking Ridge New Jersey
United States Massachusetts General Hospital Boston Massachusetts
United States The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy Chicago Illinois
United States UChicago Medicine - River East Chicago Illinois
United States University of Chicago Medical Center Chicago Illinois
United States Memorial Sloan Kettering Cancer Center at Commack Commack New York
United States Baylor University Medical Center Dallas Texas
United States Investigational Drug Services, Baylor University Medical Center Dallas Texas
United States Duke Cancer Center Durham North Carolina
United States Duke University Health System: Adult Bone Marrow Transplant Clinic Durham North Carolina
United States Duke University Hospital Durham North Carolina
United States UCSD Medical Center - Encinitas Encinitas California
United States UChicago Medicine at Ingalls - Flossmoor Flossmoor Illinois
United States Memorial Sloan Kettering Cancer Center at Westchester Harrison New York
United States UChicago Medicine Ingalls Memorial Harvey Illinois
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital) La Jolla California
United States UC San Diego Moores Cancer Center La Jolla California
United States Memorial Sloan Kettering Cancer Center at Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Cancer Center at Bergen Montvale New Jersey
United States Henry Joyce Cancer Center Nashville Tennessee
United States University of Chicago Comprehensive Cancer Center at Silver Cross Hospital New Lenox Illinois
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care New York New York
United States The University of Chicago Medicine Center for Advanced Care Orland Park Orland Park Illinois
United States UC San Diego Medical Center - Hillcrest San Diego California
United States UChicago Medicine at Ingalls - Tinley Park Tinley Park Illinois
United States Memorial Sloan Kettering Cancer Center at Nassau Uniondale New York
United States UCSD Medical Center - Vista Vista California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) Number of participants with DLTs At the end of Cycle 1 (each Cycle is 21 or 28 days)
Primary 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 From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Primary 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 From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Secondary 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 From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Secondary 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 From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Secondary 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) From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Secondary 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 From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Secondary Impact of treatment on systemic soluble immune factors Pre and post dose quantification of soluble cytokines in serum. 9 months on treatment
Secondary Maximum plasma concentration (Cmax) of PF-06863135 Peak concentration of PF-06863135 during first cycle Cycle 1 Day 1 and Cycle 2 Day 1 (3 to 4 weeks)
Secondary Trough serum concentrations of PF-06863135 and dexamethasone Trough serum concentrations of PF-06863135 and dexamethasone at selected cycles From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Secondary 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 From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
Secondary Incidence and titers of anti-drug antibodies and neutralizing antibodies against PF-06863135 Number of participants with the presence of anti-PF-06863135 antibodies From baseline and scheduled timepoints post dose through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
See also
  Status Clinical Trial Phase
Recruiting NCT05027594 - Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02412878 - Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma Phase 3
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT05971056 - Providing Cancer Care Closer to Home for Patients With Multiple Myeloma N/A
Recruiting NCT05243797 - Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation Phase 3
Active, not recruiting NCT04555551 - MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma Phase 1
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Recruiting NCT03570983 - A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion Phase 2
Completed NCT03665155 - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody Phase 1/Phase 2
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT02812706 - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients Phase 1/Phase 2
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
Active, not recruiting NCT03792763 - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients Phase 2
Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1

External Links