Dose Escalation Study of Talquetamab in Participants With... | NCT03399799

ID	Type	Description
64407564MMY1001	Other Identifier	Janssen Research & Development, LLC
2017-002400-26	EudraCT Number
2023-504581-29-00	Registry Identifier	EUCT number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1: Dose Escalation (Talquetamab) - Intravenous (IV)	Experimental	Participants will receive IV infusion of Talquetamab at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data. Participants receiving IV dosing can transition to SC dosing through-out the study upon sponsor consultation. All participants (ongoing and those who are in follow-up) will transition to open-label extension (OLE) phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the long-term extension (LTE) and will continue to receive study treatment.	Drug: Talquetamab
Part 1: Dose Escalation (Talquetamab) - Subcutaneous (SC)	Experimental	Participants will receive Talquetamab SC. The dose levels will be selected to identify safe and tolerable putative RP2D(s). All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.	Drug: Talquetamab
Part 2: Dose Expansion (Talquetamab)	Experimental	Participants will receive IV infusion or SC injection of Talquetamab at each putative recommended Phase 2 dose(s) (RP2D[s]) as determined in Part 1. Participants receiving IV dosing can transition to SC dosing through-out the study upon sponsor consultation. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Talquetamab	Drug	Participants will receive IV infusion or SC injection of Talquetamab.	Part 1: Dose Escalation (Talquetamab) - Intravenous (IV) Part 1: Dose Escalation (Talquetamab) - Subcutaneous (SC)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: Dose-limiting Toxicity (DLT)	The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non-hematological toxicity of Grade 3 or higher.	Up to Day 28
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	From signing of Informed Consent Form (ICF) up to follow up (until 100 days after the last dose of study drug or until the start of subsequent anticancer therapy, if earlier [approximately 2.10 years])

Secondary Outcomes

Measure	Description	Time Frame
Part 1: Talquetamab Serum Concentrations	Serum concentrations will be calculated for Talquetamab.	Up to 4 weeks
Part 1 and Part 2: Biomarker Assessment	Serum cytokine concentrations will be measured pre- and post-infusion of Talquetamab for biomarker assessment.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
Part 1: Participants with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies. Part 2: Participants with multiple myeloma measurable by central laboratory assessment who have progressed on, or could not tolerate, all available established therapies; Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram per 24 hours (mg/24 h) or light chain multiple myeloma without measurable disease in the serum or the urine: serum immunoglobulin free light chain (FLC) >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio; If central laboratory assessments are not available, relevant local laboratory measurements must exceed the minimum required level by at least 25%
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine
Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease

Exclusion Criteria:

Participants who received or plan to receive any live, attenuated vaccine within 4 weeks prior to the first dose, during treatment, or within 4 weeks of the last dose of Talquetamab. Non-live or non-replicating vaccines approved or authorized for emergency use (example, coronavirus disease [COVID]-19) by local health authorities are allowed
Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
An allogenic stem cell transplant within 6 months before first dose of study drug. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD); and/or an autologous stem cell transplant less than or equal to (<=) 12 weeks before first dose of study drug
Documented history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, whole body magnetic resonance imaging (MRI) and lumbar cytology are required

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama Birmingham		Birmingham	Alabama	35294	United States
City of Hope

PubMed Identifier	Type	Citation	Retractions
42299486	Derived	Schinke C, Touzeau C, Oriol A, Mateos MV, Stevens D, Rasche L, Moreau P, San-Miguel J, Rodriguez-Otero P, Kato K, Bathija S, Katz EG, Masterson T, Tomlinson C, Chari A. A plain language summary describing how talquetamab affects the way people with multiple myeloma feel and function in the MonumenTAL-1 study. Future Oncol. 2026 Jun 16:1-18. doi: 10.1080/14796694.2026.2669331. Online ahead of print.
41313549

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases