TriangleNCT05083169 · CITED IN SOURCE DOCUMENTS
A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-08-28
The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level \>=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio * Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion * Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen * Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment * Have clinical laboratory values within the specified range Exclusion Criteria: * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include: 1. A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG, 2. A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade \>= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization * Received any prior B cell maturation antigen (BCMA)-directed therapy * Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG * Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within 14 days before randomization * Received a live, attenuated vaccine within 4 weeks before randomization * Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive teclistamab and daratumumab by subcutaneous (SC) injection. Step-up doses of teclistamab will be given prior to the first full dose. Participants who are still receiving the treatment and benefiting from it may enter the long-term extension (LTE) and drug access (DA)-LTE Phases to continue their current treatment until end of the study.
- intervention Names
- Drug: Daratumumab
- Drug: Teclistamab
- label
- Arm A: Teclistamab-daratumumab (Tec-Dara)
- type
- EXPERIMENTAL
- description
- Participants will be randomized either to daratumumab, pomalidomide, dexamethasone (DPd) treatment to receive daratumumab SC injection; pomalidomide orally; dexamethasone orally or intravenously, or to Daratumumab, Bortezomib, Dexamethasone (DVd) treatment to receive daratumumab SC injection; bortezomib SC injection, and dexamethasone orally or intravenously. Participants randomized to Arm B who do not cross over to Tec-Dara may continue DPd/DVd treatment during the LTE phase. Following the completion of LTE phase, participants who crossed over to Tec-Dara during the LTE may enter the DA LTE and continue to receive study treatment with Tec Dara. Any participants still receiving DPd/DVd at the end of the LTE may not cross over to Tec-Dara and will not continue into the DA-LTE.
- intervention Names
- Drug: Daratumumab
- Drug: Pomalidomide
- Drug: Dexamethasone
- Drug: Bortezomib
- label
- Arm B: DPd or DVd
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Arm A: Teclistamab-daratumumab (Tec-Dara)
- Arm B: DPd or DVd
- description
- Daratumumab will be administered SC injection.
- name
- Daratumumab
- type
- DRUG
- arm Group Labels
- Arm B: DPd or DVd
- description
- Pomalidomide will be administered orally.
- name
- Pomalidomide
- type
- DRUG
- arm Group Labels
- Arm B: DPd or DVd
- description
- Dexamethasone will be administered orally or intravenously.
- name
- Dexamethasone
- type
- DRUG
- arm Group Labels
- Arm B: DPd or DVd
- description
- Bortezomib will be administered SC injection.
- name
- Bortezomib
- type
- DRUG
- arm Group Labels
- Arm A: Teclistamab-daratumumab (Tec-Dara)
- description
- Teclistamab will be administered SC injection.
- name
- Teclistamab
- other Names
- JNJ-64007957
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 587
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first.
- measure
- Progression Free Survival (PFS)
- time Frame
- Up to 5 years
- secondary Outcomes
- description
- Overall response (PR or better) is defined as participants who have a PR or better per IMWG criteria.
- measure
- Overall Response (Partial Response [PR] or Better)
- time Frame
- Up to 5 years
- description
- VGPR or better is defined as participants who achieve a VGPR or better response per IMWG criteria.
- measure
- Very Good Partial Response (VGPR) or Better
- time Frame
- Up to 5 years
- description
- CR or better is defined as participants who achieve a CR or better response per IMWG criteria.
- measure
- Complete Response (CR) or Better
- time Frame
- Up to 5 years
- description
- MRD-negativity is defined as participants who achieve MRD negativity at a threshold of 10\^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy.
- measure
- Minimal Residual Disease (MRD)-negativity
- time Frame
- Up to 5 years
- description
- PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.
- measure
- Progression Free Survival on Next-line Therapy (PFS2)
- time Frame
- Up to 5 years
- description
- OS is measured from the date of randomization to the date of the participant's death.
- measure
- Overall Survival (OS)
- time Frame
- Up to 5 years
- description
- TTNT is defined as the interval time from randomization to the start of subsequent antimyeloma treatment.
- measure
- Time to Next Treatment (TTNT)
- time Frame
- Up to 5 years
- description
- Duration of response will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria, or death due to any cause, whichever occurs first.
- measure
- Duration of Response
- time Frame
- Up to 5 years
- description
- Number of participants with AEs by Severity will be reported.
- measure
- Number of Participants with Adverse Events (AEs) by Severity
- time Frame
- Up to 5 years
- description
- Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive method.
- measure
- Serum Concentration of Teclistamab
- time Frame
- Up to 5 years
- description
- Number of participants with ADAs to teclistamab and daratumumab will be reported.
- measure
- Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Daratumumab
- time Frame
- Up to 5 years
- description
- Time to worsening is measured as the interval from the date of randomization to the start date of meaningful change.
- measure
- Time to Worsening of Symptoms
- time Frame
- Up to 5 years
Full study description
- brief Summary
- The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).
Source references
- references
- citation
- Costa LJ, Bahlis NJ, Perrot A, Nooka AK, Lu J, Pawlyn C, Mina R, Caeiro G, Kentos A, Hungria V, Reece D, Niu T, Mylin AK, Hansen CT, Teipel R, Besemer B, Dimopoulos MA, Zamagni E, Yoshihara S, Kim K, Min CK, Geerts P, Van Leeuwen-Segarceanu E, Tyczynska A, Reguera JL, Johansson M, Hansson M, Turgut M, Grey M, Sidana S, Rodriguez-Otero P, Martinez-Lopez J, Hashmi H, Carson R, Kobos R, Sun W, Lantz K, Seifert A, Briseno-Toomey D, O'Rourke L, Rubin M, Vieyra D, Kang L, Mateos MV; MajesTEC-3 Trial Investigators. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2026 Feb 19;394(8):739-752. doi: 10.1056/NEJMoa2514663. Epub 2025 Dec 9.
- pmid
- 41363801
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- dexamethasone (DVd) was evaluated in adult patients with relapsed or refractory multiple myeloma in a randomized, open-label, multi-center study (MajesTEC-3) (NCT05083169). The study included patients who had previously received one to three prior lines of therapy including a proteasome inhibitor and lenalidomide. Patients who h
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- ww.accessdata.fda.gov/scripts/cder/daf/index.cfm">Drugs@FDA</a>. </p><h2><strong>Efficacy and Safety</strong></h2><p>Efficacy was evaluated in MajesTEC-3 (NCT05083169), a randomized, open-label, multi-center trial. A total of 587 patients were randomized in the trial to the teclistamab and daratumumab hyaluronidase-fihj grou
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Preserved source evidence · Not medical advice