Multiple Myeloma Clinical Trial
A Study to Learn About the Study Medicine (Elranatamab) Either Alone or in Combination With Dexamethasone in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment
Summary
The purpose of this study is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses.
Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.
Full Description
The purpose of Part 1 and Part 2 of the study is to evaluate the safety (in particular the rate of Grade ≥ 2 CRS) of a step-up priming dose regimen of elranatamab in participants with relapsed/refractory multiple myeloma. The purpose of Part 3 is to evaluate the safety and efficacy of elranatamab in combination with dexamethasone during the first 6 cycles followed by elranatamab monotherapy. In addition, this study will assess the safety of different dosing regimens of elranatamab and if it can provide a clinical benefit in those participants. Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
Measurable disease, as defined by at least 1 of the following:
Serum M-protein >0.5 g/dL by SPEP
Urinary M-protein excretion >200 mg/24 hours by UPEP
Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
Refractory to at least one IMiD
Refractory to at least one PI
Refractory to at least one anti-CD38 antibody
Relapsed/refractory to last anti-myeloma regimen
ECOG performance status ≤1
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
Not pregnant and willing to use contraception
Exclusion Criteria:
Smoldering multiple myeloma
Active Plasma cell leukemia
POEMS syndrome
Amyloidosis
Waldenström's macroglobulinemia
Known active CNS involvement or clinical signs of myelomatous meningeal involvement
Stem cell transplant within 12 weeks prior to enrollment or active GVHD
Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
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 or Stage 0/1 malignancy with minimal risk of recurrence per investigator.
Previous treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy.
Live attenuated vaccine within 4 weeks of the first dose
Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
Known or suspected hypersensitivity to the study intervention, or any of its excipients or unable to tolerate systemic corticosteroids at doses planned to be administered in the study Part 3
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There are 37 Locations for this study
Phoenix Arizona, 85054, United States
Scottsdale Arizona, 85259, United States
Fort Collins Colorado, 80524, United States
Fort Collins Colorado, 80528, United States
Greeley Colorado, 80634, United States
Loveland Colorado, 80538, United States
Gainesville Florida, 32608, United States
Gainesville Florida, 32610, United States
Pikeville Kentucky, 41501, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
Boston Massachusetts, 02111, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Montvale New Jersey, 07645, United States
New York New York, 10021, United States
New York New York, 10065, United States
Uniondale New York, 11553, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19111, United States
Austin Texas, 78704, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84112, United States
Nagoya Aichi, 467-8, Japan
Kobe-city Hyogo, 650-0, Japan
Chuo-ku Tokyo, 104-0, Japan
Shibuya-ku Tokyo, 150-8, Japan
Kyoto , 602-8, Japan
Taichung , 40447, Taiwan
Tainan , 704, Taiwan
Taipei City , 11217, Taiwan
Taipei , 10002, Taiwan
Southampton Hampshire, SO16 , United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Birmingham , B15 2, United Kingdom
London , SE1 9, United Kingdom
London , SE5 9, United Kingdom
London , W1T 7, United Kingdom
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