Clinical trial NCT05338775: 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
Official title: A Phase 1b Study of Bispecific T Cell Redirection Antibodies in Combination With Checkpoint Inhibition for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Relapsed/ Refractory Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-04-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.


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

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 2 years 5 months
measure: Number of Participants with Adverse Events (AEs) by Severity
timeFrame: Up to 2 years 5 months
measure: Number of Participants with Abnormalities in Clinical Laboratory Assessments
timeFrame: Up to 2 years 5 months
measure: Number of Participants with Dose-Limiting Toxicity (DLTs)
timeFrame: Up to 2 years 5 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 2 years 5 months
measure: Very Good Partial Response (VGPR) or Better Response Rate
timeFrame: Up to 2 years 5 months
measure: Complete Response (CR) or Better Response Rate
timeFrame: Up to 2 years 5 months
measure: Stringent Complete Response (sCR) Rate
timeFrame: Up to 2 years 5 months
measure: Duration of Response
timeFrame: Up to 2 years 5 months
measure: Time to Response
timeFrame: Up to 2 years 5 months
measure: Serum Concentrations of Talquetamab
timeFrame: Up to 2 years 5 months
measure: Serum Concentrations of Teclistamab
timeFrame: Up to 2 years 5 months
measure: Serum Concentrations of PD-1 Inhibitor
timeFrame: Up to 2 years 5 months
measure: Number of Participants with Anti-Talquetamab Antibodies
timeFrame: Up to 2 years 5 months
measure: Number of Participants with Anti-Teclistamab Antibodies
timeFrame: Up to 2 years 5 months
measure: Number of Participants with Anti-PD-1 Inhibitor Antibodies
timeFrame: Up to 2 years 5 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: New York
country: United States
facility: The Blavatnik Family Chelsea Medical Center at Mount Sinai
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center
state: Tennessee
city: Montpellier Cedex 5
country: France
facility: CHU de Montpellier Hopital Saint Eloi
city: Nantes Cedex 1
country: France
facility: CHU de Nantes hotel Dieu
city: Poitiers
country: France
facility: CHU Poitiers - Hopital la Miletrie
city: Toulouse Cedex 9
country: France
facility: Institut Universitaire du Cancer Toulouse Oncopole
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus Dresden
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Wuerzburg
country: Germany
facility: Universitatsklinikum Wurzburg
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Madrid
country: Spain
facility: Hosp Univ Fund Jimenez Diaz
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
Study officials:
affiliation: Janssen Research and Development LLC
name: Janssen Research and Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: