A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma

Running, not enrolling · Phase 1

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab with or without pomalidomide) and to characterize the safety of each RP2D for selected treatment combinations.

Key facts

Study ID

NCT04108195

Run by

Janssen Research & Development, LLC

People needed

290

Starts

2020-02-21

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…

• Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
• Must have either of the following: a) received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the treatment or b) disease that is double refractory to a PI and an IMiD
• Measurable disease at screening as defined by any of the following: Serum monoclonal protein (M-protein) level >=1.0 grams per deciliter (g/dL) (in non- immunoglobulin G (IgG) myeloma, an M-protein level >=0.5 g/dL); or Urine M-protein level >=200 milligrams (mg)/24 hours; or 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
• Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and at Cycle 1, Day 1 predose
• Female participants of childbearing potential must have a negative highly-sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test (less than [<] 5 international units per milliliter [IU/mL]) at screening and a negative urine or serum pregnancy test within 1 day before the first dose of study drug

You may not qualify if…

• Treatment in the prior 3 months with an anti- cluster of differentiation 38 (CD38) therapy (example, daratumumab), or discontinuation of a prior anti-CD38 therapy at any time due to an adverse event related to the anti-CD38 therapy
• Live, attenuated vaccine within 4 weeks prior to the first dose of study drug unless approved by sponsor
• Active Central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
• Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded
• Active hepatitis C infection as measured by positive hepatitis C virus- ribonucleotide (HCV)-RNA testing. Participants with a history of Hepatitis C virus antibody positivity must undergo HCV-RNA testing

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States
• University of California San Francisco — San Francisco, California, United States
• The Blavatnik Family Chelsea Medical Center at Mount Sinai — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
• Medical College Of Wisconsin — Milwaukee, Wisconsin, United States
• Arthur J E Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
• University Health Network UHN Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Universitatsklinikum Freiburg — Freiburg im Breisgau, Germany
• Universitaetsklinikum Hamburg Eppendorf — Hamburg, Germany
• Universitaetsklinikum Heidelberg — Heidelberg, Germany
• Universitatsklinikum Wurzburg — Würzburg, Germany
• VU Medisch Centrum — Amsterdam, Netherlands
• LUMC — Leiden, Netherlands
• Hosp Clinic de Barcelona — Barcelona, Spain
• Inst. Cat. Doncologia-H Duran I Reynals — Barcelona, Spain
• Germans Trias I Pujol — Barcelona, Spain
• Hosp Univ Fund Jimenez Diaz — Madrid, Spain
• Clinica Univ. de Navarra — Pamplona, Spain
• Hosp Clinico Univ de Salamanca — Salamanca, Spain

Full record on ClinicalTrials.gov

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