A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT05338775
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
74 participants
INTERVENTIONAL
2022-05-25
2027-05-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Escalation
Participants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly.
Talquetamab
Talquetamab will be administered as a subcutaneous (SC) injection.
Teclistamab
Teclistamab will be administered as a SC injection.
PD-1 Inhibitor
The PD-1 inhibitor will be administered as an intravenous injection.
Part 2: Dose Expansion
Participants will receive either treatment regimen A or treatment regimen B with a PD-1 inhibitor at the dose levels identified in Part 1.
Talquetamab
Talquetamab will be administered as a subcutaneous (SC) injection.
Teclistamab
Teclistamab will be administered as a SC injection.
PD-1 Inhibitor
The PD-1 inhibitor will be administered as an intravenous injection.
Interventions
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Talquetamab
Talquetamab will be administered as a subcutaneous (SC) injection.
Teclistamab
Teclistamab will be administered as a SC injection.
PD-1 Inhibitor
The PD-1 inhibitor will be administered as an intravenous injection.
Eligibility Criteria
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Inclusion 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 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research and Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research and Development LLC
Locations
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Colorado Blood Cancer Institute
Denver, Colorado, United States
The Blavatnik Family Chelsea Medical Center at Mount Sinai
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
CHU de Montpellier Hopital Saint Eloi
Montpellier, , France
CHU de Nantes hotel Dieu
Nantes, , France
CHU Poitiers - Hopital la Miletrie
Poitiers, , France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, , France
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitatsklinikum Wurzburg
Würzburg, , Germany
Hosp. Univ. Germans Trias I Pujol
Badalona, , Spain
Hosp Univ Fund Jimenez Diaz
Madrid, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Countries
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Other Identifiers
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64407564MMY1005
Identifier Type: OTHER
Identifier Source: secondary_id
2021-005073-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-502681-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109168
Identifier Type: -
Identifier Source: org_study_id