Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Trial acronym
MonumenTAL-2
Clinical summary
Summary
This is a non-randomised trial that has five experimental arms. In Experimental Arm A, participants will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion. In Experimental Arm B, participants will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. In Experimental Arm C, participants will receive talquetamab SC in combination with lenalidomide orally. In Experimental Arm D, participants will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally. In Experimental Arm E, participants will receive talquetamab SC in combination with pomalidomide orally.
Conditions
This trial is treating people with multiple myeloma
Eligibility
Inclusion
- Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level >= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration
- A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration
- Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program
Exclusion
- Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the start of study treatment administration
- Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Known to be seropositive for human immunodeficiency virus
- History of stroke or seizure within 6 months prior to the first dose of study treatment
Inclusion
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Janssen Research & Development, LLC
Scientific Title
A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
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