Multiple Myeloma Clinical Trial
A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma
The purpose of this study is to understand the effects of elranatamab plus carfilzomib and dexamethasone for the treatment of people with multiple myeloma. Multiple myeloma is a form of cancer in the bone that forces healthy blood cells out. The investigators are seeking people who:
Are male and female with multiple myeloma.
Have received at least 1 but no more than 3 lines of therapy for multiple myeloma.
Are 18 years of age or older.
A female participant is eligible if she is not pregnant or breastfeeding. She is required to use birth control throughout the study.
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 will receive the first dose of carfilzomib to see if it is safe. Afterwards, they will receive weekly carfilzomib as an IV infusion (given directly into a vein). Participants will also receive weekly dexamethasone either by mouth (as a pill) or by IV infusion.
The investigators will examine the experiences of people receiving the study medicines. This will help participants 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.
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 â‰¥0.5 g/dL.
Urinary M-protein excretion â‰¥200 mg/24 hours.
Serum immunoglobulin FLC â‰¥10 mg/dL (â‰¥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 â‰¤1.
Not pregnant or breastfeeding and willing to use contraception.
Prior therapy with carfilzomib is allowed as long as the participant had (all apply): responded to most recent therapy with carfilzomib; Carfilzomib was not discontinued due to toxicity; Did not relapse within 60 days from discontinuation of carfilzomib; Will have at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment.
Plasma cell leukemia, Smouldering MM, WaldenstrÃ¶ms 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.
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.
Participants who are unable to tolerate carfilzomib due to suspected carfilzomib-related congestive heart failure or thrombotic microangiopathy.
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There are 2 Locations for this study
Beverly Hills California, 90211, United States
Iowa City Iowa, 52242, United States
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