Clinical trial · Interventional
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
NCT04108195CI-TRIAL-00124342active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daratumumab | Drug | Daratumumab | ALIAS |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
| Talquetamab | Drug | Talquetamab | ALIAS |
| Teclistamab | Drug | Teclistamab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Escalation
- description
- Participants will be assigned to either a combination of 1) daratumumab plus teclistamab or 2) daratumumab plus talquetamab or 3) daratumumab plus talquetamab plus pomalidomide or 4) daratumumab plus teclistamab plus pomalidomide.
- interventionNames
- Drug: Daratumumab
- Drug: Talquetamab
- Drug: Teclistamab
- Drug: Pomalidomide
- type
- EXPERIMENTAL
- label
- Part 2: Dose Expansion
- description
- Participants will be treated with the RP2D(s) for selected treatment combinations determined in Part 1.
- interventionNames
- Drug: Daratumumab
- Drug: Talquetamab
- Drug: Teclistamab
- Drug: Pomalidomide
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (3)
- DERIVEDRodriguez-Otero P, Morillo D, D'Souza A, Reece D, van de Donk N, Chari A, Dholaria B, Kortum KM, Mateos MV, Mckay JT, Rosinol L, Sureda A, Wasch R, Bhutani M, Weisel KC, Bahlis NJ, Vishwamitra D, Skerget S, Bakshi KK, Guo Y, Sun W, Goldberg JD, Stephenson T, Prior TJ, Vandenberk L, Lee S, Smit MD, Verona RI, Oriol A, Krishnan A. Teclistamab and Daratumumab Immune-Based Doublet Therapy for Relapsed/Refractory Multiple Myeloma: the TRIMM-2 Study. Blood Adv. 2026 Sep 2:bloodadvances.2026020648. doi: 10.1182/bloodadvances.2026020648. Online ahead of print. PMID 42685673
- DERIVEDChari A, van de Donk NWCJ, Dholaria B, Weisel K, Mateos MV, Goldschmidt H, Martin TG, Morillo D, Reece D, Rodriguez-Otero P, Bhutani M, D'Souza A, Oriol A, Rosinol L, Bahlis NJ, Vishwamitra D, Skerget S, Verona RI, Bakshi K, Kang L, Prior TJ, Vandenberk L, Tolbert J, Lee S, Smit MD, Wasch R. Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study. Blood. 2025 Dec 11;146(24):2902-2913. doi: 10.1182/blood.2025029360. PMID 40983036
- DERIVEDPillarisetti K, Powers G, Luistro L, Babich A, Baldwin E, Li Y, Zhang X, Mendonca M, Majewski N, Nanjunda R, Chin D, Packman K, Elsayed Y, Attar R, Gaudet F. Teclistamab is an active T cell-redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma. Blood Adv. 2020 Sep 22;4(18):4538-4549. doi: 10.1182/bloodadvances.2020002393. PMID 32956453