A Study of Talquetamab and Teclistamab Each in Combinatio... | NCT05338775

NCT05338775

ID	Type	Description
64407564MMY1005	Other Identifier	Janssen Research & Development, LLC
2021-005073-22	EudraCT Number
2022-502681-24-00	Registry Identifier	EUCT number

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1: Dose Escalation	Experimental	Participants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly.	Drug: Talquetamab Drug: Teclistamab Drug: PD-1 Inhibitor
Part 2: Dose Expansion	Experimental	Participants will receive either treatment regimen A or treatment regimen B with a PD-1 inhibitor at the dose levels identified in Part 1.	Drug: Talquetamab Drug: Teclistamab Drug: PD-1 Inhibitor

Name	Type	Description	Arm Group Labels	Other Names
Talquetamab	Drug	Talquetamab will be administered as a subcutaneous (SC) injection.	Part 1: Dose Escalation Part 2: Dose Expansion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events (AEs)	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.	Up to 2 years 5 months
Number of Participants with Adverse Events (AEs) by Severity	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. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.	Up to 2 years 5 months
Number of Participants with Abnormalities in Clinical Laboratory Assessments	Number of participants with abnormalities in clinical laboratory assessments (serum chemistry and hematology) will be reported.	Up to 2 years 5 months
Number of Participants with Dose-Limiting Toxicity (DLTs)	The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.	Up to 2 years 5 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria.	Up to 2 years 5 months
Very Good Partial Response (VGPR) or Better Response Rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
Participants with relapsed or refractory disease that are not a candidate for available therapy with established clinical benefit
Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); b) Urine M-protein level >= 200 milligrams (mg) per 24 hours; c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams/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

Exclusion Criteria:

Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or autologous stem cell transplant within 3 months)
Prior therapy with PD-1 inhibitors, allogeneic stem cell transplant or solid organ transplant
Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
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
Live, attenuated vaccine within 4 weeks before the first dose of study treatment
Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia [any grade] or peripheral neuropathy to Grade <= 2)
Received a cumulative dose of corticosteroids equivalent to >= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration

Name	Affiliation	Role
Janssen Research and Development, LLC Clinical Trial	Janssen Research and Development LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Colorado Blood Cancer Institute		Denver	Colorado	80218	United States
The Blavatnik Family Chelsea Medical Center at Mount Sinai

IPD Sharing Statement Module

ID	Term
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D000074322	Antineoplastic Agents, Immunological
D000970	Antineoplastic Agents
D045506	Therapeutic Uses