NCT04108195Active, not recruitingPhase 1
A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma
A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Subjects With Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 290 (actual)
- First submitted
- 26 Sept 2019
- Start date
- 21 Feb 2020
- Primary completion date
- 7 Apr 2027
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Multiple myeloma
- NCT number
- NCT04108195
- EU CT number
- 2023-503468-17-00
- EudraCT number
- 2019-000330-19
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 290
- From 21 Feb 2020 to the primary completion date, 7 Apr 2027
- 22 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arthur J.E. Child Comprehensive Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| University Health Network UHN Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Active, not recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Active, not recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| City of Hope Orange County Lennar Foundation Cancer Center Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Vanderbilt-Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| The Blavatnik Family ? Chelsea Medical Center at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount SInai Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Wake Forest Baptist Medical Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
Related publications
- Teclistamab and Daratumumab Immune-Based Doublet Therapy for Relapsed/Refractory Multiple Myeloma: the TRIMM-2 Study.Blood Adv · 2026 · PMID 42685673
This page is information, not medical advice. Discuss any trial with your doctor.