A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Running, not enrolling · Phase 1
Conditions studied: Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT05050097
- Run by
- Janssen Research & Development, LLC
- People needed
- 166
- Starts
- 2021-09-22
- Expected to finish
- 2027-04-07
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama Birmingham — Birmingham, Alabama, United States
- University of California San Francisco — San Francisco, California, United States
- Colorado Blood Cancer Institute — Denver, Colorado, United States
- Emory University — Atlanta, Georgia, United States
- Indiana University — Indianapolis, Indiana, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Mt. Sinai School of Medicine — New York, New York, United States
- Weill Cornell Medical College — New York, New York, United States
- Levine Cancer Institute — Charlotte, North Carolina, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Tennessee Oncology — Nashville, Tennessee, United States
- Medical College Of Wisconsin — Milwaukee, Wisconsin, United States
- St Vincents Hospital Melbourne — Fitzroy, Australia
- Alfred Health — Melbourne, Australia
- Gold Coast University Hospital — Southport, Australia
- Wollongong Hospital — Wollongong, Australia
- Cliniques Universitaires St-Luc — Brussels, Belgium
- UZA — Edegem, Belgium
- UZ Gent — Ghent, Belgium
- UZ Leuven — Leuven, Belgium
- CHU Nantes — Nantes, France
- CHU de Bordeaux - Hospital Haut-Leveque — Pessac, France
- Chu Rennes Hopital Pontchaillou — Rennes, France
- Institut Universitaire du cancer de Toulouse-Oncopole — Toulouse, France
- UMCG — Groningen, Netherlands
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.