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RecruitingLast updated: 7 February 2024

MonumenTAL-2: This phase I study is evaluating how safe and tolerable a targeted therapy (talquetamab) is when administered in different combinations with other cancer drugs (including carfilzomib, daratumumab, lenalidomide and pomalidomide) in people with multiple myelomaA Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

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 patients with multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

MonumenTAL-2

More information

Trial Identifiers

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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

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.
Message

Clinical trials have complex eligibility criteria.

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