Study Comparing Teclistamab with Daratumumab and Other Treatments for Relapsed or Refractory Multiple Myeloma

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT05083169

This clinical trial is comparing the effectiveness of a new combination treatment, Teclistamab with Daratumumab, against other standard treatments for patients with multiple myeloma that has returned or not responded to previous therapies.

Patient Parameters

Program Overview

The aim of this study is to see how well a new treatment combination, Teclistamab with Daratumumab, works compared to other existing treatments for patients with multiple myeloma that has come back or is not responding to treatment. The study will compare this new combination to two other treatment options: Daratumumab with Pomalidomide and Dexamethasone, and Daratumumab with Bortezomib and Dexamethasone.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of multiple myeloma based on specific medical criteria.
  • Have measurable disease at the time of screening, which can be detected through blood or urine tests.
  • Have received 1 to 3 previous treatments for multiple myeloma, including a proteasome inhibitor and lenalidomide.
  • If only one previous treatment was received, the disease must not have responded to lenalidomide.
  • Show evidence of disease progression after the last treatment.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2.
  • Have laboratory test results within specified normal ranges.

Exclusion Criteria

  • Have severe allergies or intolerances to any of the study drugs or their ingredients.
  • Cannot receive Daratumumab with Pomalidomide and Dexamethasone if allergic to Pomalidomide or if the disease does not respond to Pomalidomide.
  • Cannot receive Daratumumab with Bortezomib and Dexamethasone if allergic to Bortezomib, have certain nerve problems, or if the disease does not respond to Bortezomib.
  • Have received any previous treatment targeting BCMA.
  • Have disease that does not respond to anti-CD38 monoclonal antibodies.
  • Have taken high doses of corticosteroids recently.
  • Have received a live vaccine within the last four weeks.
  • Have certain other blood disorders or conditions like plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloidosis.

Locations

FACILITYZIPCITYSTATE
University of Alabama Birmingham35294BirminghamAlabama
City of Hope91010DuarteCalifornia
Stanford University Medical Center94305-5623StanfordCalifornia
Yale University06510New HavenConnecticut
Emory University Winship Cancer Institute30322AtlantaGeorgia
Tufts Medical Center02111BostonMassachusetts
Henry Ford Hospital48202DetroitMichigan
Henry Ford Health System48075SouthfieldMichigan
Cleveland Clinic44195ClevelandOhio
West Penn Hospital15224PittsburghPennsylvania

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