A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MonumenTAL-2)

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Lenalidomide; Drug: Carfilzomib; Drug: Talquetamab; Drug: Pomalidomide; Drug: Daratumumab SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT05050097

CR108946

2023-503620-60-00 (Registry Identifier)

64407564MMY1004 (Other Identifier)

2020-004502-55 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 5 patient groups

Treatment Regimen A: Talquetamab + Carfilzomib

Experimental group

Description:

Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion.

Treatment:

Drug: Talquetamab

Drug: Carfilzomib

Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib

Experimental group

Description:

Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion.

Treatment:

Drug: Daratumumab SC

Drug: Talquetamab

Drug: Carfilzomib

Treatment Regimen C: Talquetamab + Lenalidomide

Experimental group

Description:

Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.

Treatment:

Drug: Talquetamab

Drug: Lenalidomide

Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide

Experimental group

Description:

Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.

Treatment:

Drug: Daratumumab SC

Drug: Talquetamab

Drug: Lenalidomide

Treatment Regimen E: Talquetamab + Pomalidomide

Experimental group

Description:

Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.

Treatment:

Drug: Pomalidomide

Drug: Talquetamab