Trial Title:
A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma
NCT ID:
NCT05675449
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
elranatamab
relapsed
RRMM
BCMA
C1071020
MagnetisMM
maplipacelt
PF-06863135
carfilzomib
Bispecific antibody
PF-07901801
TTI-622
SIRPα
CD47
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Elranatamab
Description:
BCMA-CD3 bispecific antibody
Arm group label:
Part 1 Dose Escalation
Arm group label:
Part 2A Dose Escalation
Arm group label:
Part 2B Dose Randomization
Other name:
PF-06863135
Intervention type:
Drug
Intervention name:
Carfilzomib
Description:
proteasome inhibitor
Arm group label:
Part 1 Dose Escalation
Other name:
Kyprolis
Intervention type:
Drug
Intervention name:
Maplirpacept
Description:
CD47-SIRP alpha-directed
Arm group label:
Part 2A Dose Escalation
Arm group label:
Part 2B Dose Randomization
Other name:
PF-07901801, TTI-622
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Prior diagnosis of multiple myeloma as defined by IMWG criteria.
- Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL.
- Urinary M-protein excretion ≥200 mg/24 hours.
- Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum
immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
- 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).
- 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.
- ECOG performance status 0-1.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
- Not pregnant or breastfeeding and willing to use contraception.
Exclusion Criteria:
- Plasma cell leukemia, Smouldering MM, Waldenströms macroglobulinemia, Amyloidosis,
POEMS Syndrome, Primary refractory MM
- Impaired cardiovascular function or clinically significant cardiovascular diseases.
- Participants with any active, uncontrolled bacterial, fungal, or viral infection.
- Stem cell transplant within 12 weeks prior to enrollment, or active graft versus
host disease.
- 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.
- Part 1: Previous treatment with a BCMA-directed therapy.
- 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.
- Part 1: Prior treatment with carfilzomib
- Live attenuated vaccine within 4 weeks of the first dose of study intervention.
- 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.
- 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.
- Intolerance to or participants who have had a severe (Grade ≥3) allergic or
anaphylactic reaction to antibodies or therapeutic proteins
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Arkansas for Medical Sciences
Address:
City:
Little Rock
Zip:
72205
Country:
United States
Status:
Recruiting
Facility:
Name:
Beverly Hills Cancer Center
Address:
City:
Beverly Hills
Zip:
90211
Country:
United States
Status:
Recruiting
Facility:
Name:
Sylvester Comprehensive Cancer Center - Aventura
Address:
City:
Aventura
Zip:
33180
Country:
United States
Status:
Recruiting
Facility:
Name:
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Address:
City:
Coral Gables
Zip:
33146
Country:
United States
Status:
Recruiting
Facility:
Name:
Sylvester Comprehensive Cancer Center - Coral Springs
Address:
City:
Coral Springs
Zip:
33065
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Miami Hospital and Clinics - Deerfield Beach
Address:
City:
Deerfield Beach
Zip:
33442
Country:
United States
Status:
Recruiting
Facility:
Name:
Sylvester Comprehensive Cancer Center - Hollywood
Address:
City:
Hollywood
Zip:
33021
Country:
United States
Status:
Recruiting
Facility:
Name:
Sylvester Comprehensive Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Miami Hospital And Clinics
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Facility:
Name:
Sylvester Comprehensive Cancer Center - Kendall
Address:
City:
Miami
Zip:
33176
Country:
United States
Status:
Recruiting
Facility:
Name:
Sylvester Comprehensive Cancer Center - Plantation
Address:
City:
Plantation
Zip:
33324
Country:
United States
Status:
Recruiting
Facility:
Name:
Emory University Hospital Midtown
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Status:
Recruiting
Facility:
Name:
Emory University Hospital
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Facility:
Name:
Emory University School of Medicine Investigational Drug Service
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Winship Cancer Institute of Emory University
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Iowa Hospitals and Clinics
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Investigational Drug Service,Department of Pharmacy Services
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Status:
Recruiting
Facility:
Name:
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Status:
Recruiting
Facility:
Name:
Johns Hopkins Medicine
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
MSK Monmouth
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
Address:
City:
New York
Zip:
10021
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center - Main Campus
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry-Joyce Cancer Clinic
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Facility:
Name:
Vanderbilt University Medical Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Facility:
Name:
Rambam Health Care Campus
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Division of Hematology Hadassah Medical Center - Ein Kerem
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center - Ein Kerem
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hematology Division Davidoff Center, Rabin Medical Center, Bellinson Hospital
Address:
City:
Petach Tikvah
Zip:
4941494
Country:
Israel
Status:
Not yet recruiting
Facility:
Name:
Hematology Division Davidoff Center, Rabin Medical Center, Beilinson Hospital
Address:
City:
Petah Tikva
Zip:
4941492
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hematology Division Davidoff Center, Rabin Medical Center, Beilinson Hospital
Address:
City:
Petah Tikva
Zip:
4941494
Country:
Israel
Status:
Not yet recruiting
Facility:
Name:
The Chaim Sheba Medical Center
Address:
City:
Ramat-Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Tel-Aviv Sourasky Medical Center
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Start date:
December 14, 2022
Completion date:
November 5, 2027
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05675449
https://pmiform.com/clinical-trial-info-request?StudyID=C1071020
