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Comparing teclistamab to standard treatments for relapsed or refractory multiple myeloma

A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

Phase 3 Interventional Janssen Research & Development, LLC · NCT05572515

This study is testing if a new treatment called teclistamab works better than standard therapies for people with relapsed or refractory multiple myeloma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment650 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsprednisone, teclistamab
Locations209 sites (Anchorage, Alaska and 208 other locations)
Trial IDNCT05572515 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of teclistamab monotherapy compared to standard treatment regimens, specifically Pomalidomide, Bortezomib, Dexamethasone (PVd) and Carfilzomib, Dexamethasone (Kd), in patients with relapsed or refractory multiple myeloma. The trial is divided into two parts: the first part focuses on comparing the efficacy of teclistamab with the standard treatments, while the second part seeks to further assess the safety and efficacy of an alternative dosing regimen for teclistamab. Participants must have measurable disease and a documented history of multiple myeloma, having received prior therapies. The study is interventional and is currently in Phase 3.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with a documented diagnosis of relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

Not a fit: Patients who have not received prior anti-CD38 monoclonal antibody therapy or lenalidomide may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with relapsed or refractory multiple myeloma.

How similar studies have performed: Other studies have shown promising results with similar monoclonal antibody therapies in treating multiple myeloma, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to 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 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level \>=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain \>=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
* Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line
* Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
* Must be willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

* Received any prior B cell maturation antigen (BCMA)-directed therapy
* A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (\>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (\>)159 millimeters of mercury (mmHg) or diastolic blood pressure \>99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade \>=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event \[AE\] related to carfilzomib)
* Received a maximum cumulative dose of corticosteroids of \>=140 mg of prednisone or equivalent within 14 days prior to randomization
* Received a live, attenuated vaccine within 4 weeks before randomization
* Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma
* Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis

Where this trial is running

Anchorage, Alaska and 208 other locations

+159 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed or Refractory Multiple Myeloma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.