RECRUITING

A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of the study is to evaluate the safety and tolerability of the combination of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept. There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms. The first will evaluate the safety and tolerability of elranatamab when given in combination with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus maplirpacept. All study medicines are given over 4-week cycles. Everyone taking part in this study will receive elranatamab as a shot under the skin. Participants in Part 1 will also receive weekly carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth (as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination with maplirpacept as an IV infusion (given directly into a vein) The investigators will examine the experiences of people receiving the study medicines. This will help determine if the study medicines are safe and can be used for multiple myeloma treatment. Participants will take part in this study for about 2 years after the first dose.

Official Title

A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH CARFILZOMIB PLUS DEXAMETHASONE AND ELRANATAMAB IN COMBINATION WITH PF-07901801 IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA

Quick Facts

Study Start:2022-12-14
Study Completion:2027-11-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05675449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Prior diagnosis of multiple myeloma as defined by IMWG criteria.
  2. * Measurable disease based on IMWG criteria as defined by at least 1 of the following:
  3. * Serum M-protein ≥0.5 g/dL.
  4. * Urinary M-protein excretion ≥200 mg/24 hours.
  5. * Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
  6. * Part 1: Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy).
  7. * Part 2: Received at least 3 prior lines of therapy for multiple myeloma who are refractory to at least one IMiD, one PI and one anti-CD38 antibody.
  8. * ECOG performance status 0-1.
  9. * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
  10. * Not pregnant or breastfeeding and willing to use contraception.
  1. * Plasma cell leukemia, Smouldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome, Primary refractory MM
  2. * Impaired cardiovascular function or clinically significant cardiovascular diseases.
  3. * Participants with any active, uncontrolled bacterial, fungal, or viral infection.
  4. * Stem cell transplant within 12 weeks prior to enrollment, or active graft versus host disease.
  5. * Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  6. * Part 1: Previous treatment with a BCMA-directed therapy.
  7. * Part 2: Previous treatment with any anti-BCMA directed therapy, with the exception of CAR-T. Previous treatment with a CD47-SIRP alpha-directed therapy.
  8. * Part 1: Prior treatment with carfilzomib
  9. * Live attenuated vaccine within 4 weeks of the first dose of study intervention.
  10. * Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.
  11. * Any of the following within 3 months of enrollment: erosive esophagitis, treatment resistant peptic ulcer, infectious or inflammatory bowel disease, pulmonary embolism or uncontrolled thromboembolic event.
  12. * Intolerance to or participants who have had a severe (Grade ≥3) allergic or anaphylactic reaction to antibodies or therapeutic proteins

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211
United States
Sylvester Comprehensive Cancer Center - Aventura
Aventura, Florida, 33180
United States
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables, Florida, 33146
United States
Sylvester Comprehensive Cancer Center - Coral Springs
Coral Springs, Florida, 33065
United States
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, 33442
United States
Sylvester Comprehensive Cancer Center - Hollywood
Hollywood, Florida, 33021
United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
University of Miami Hospital And Clinics
Miami, Florida, 33136
United States
Sylvester Comprehensive Cancer Center - Kendall
Miami, Florida, 33176
United States
Sylvester Comprehensive Cancer Center - Plantation
Plantation, Florida, 33324
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Emory University School of Medicine Investigational Drug Service
Atlanta, Georgia, 30322
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
United States
Winship Cancer Institute
Atlanta, Georgia, 30322
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Oncology Investigational Drug Service,Department of Pharmacy Services
Baltimore, Maryland, 21231
United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States
Johns Hopkins Medicine
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
MSK Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021
United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-14
Study Completion Date2027-11-05

Study Record Updates

Study Start Date2022-12-14
Study Completion Date2027-11-05

Terms related to this study

Keywords Provided by Researchers

  • elranatamab
  • relapsed
  • RRMM
  • BCMA
  • C1071020
  • MagnetisMM
  • maplipacelt
  • PF-06863135
  • carfilzomib
  • Bispecific antibody
  • PF-07901801
  • TTI-622
  • SIRPα
  • CD47

Additional Relevant MeSH Terms

  • Multiple Myeloma