ACTIVE_NOT_RECRUITING

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd in Part 1 and to further characterize safety and efficacy of an alternative dosing for teclistamab in Part 2 in participants with relapsed or refractory multiple myeloma.

Official Title

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

Quick Facts

Study Start:2023-03-29
Study Completion:2031-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05572515

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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
  3. * 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
  4. * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  5. * 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
  6. * Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
  1. * Received any prior B cell maturation antigen (BCMA)-directed therapy
  2. * 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)
  3. * Received a maximum cumulative dose of corticosteroids of \>=140 mg of prednisone or equivalent within 14 days prior to randomization
  4. * Received a live, attenuated vaccine within 4 weeks before randomization
  5. * Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma
  6. * 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

Contacts and Locations

Principal Investigator

Janssen Research & Development, LLC Clinical Trial
STUDY_DIRECTOR
Janssen Research & Development, LLC

Study Locations (Sites)

Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
United States
MemorialCare Long Beach Medical Center
Long Beach, California, 90806
United States
University of California Irvine
Orange, California, 92868
United States
PIH Health Hospital
Whittier, California, 90602
United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80218
United States
University of Connecticut
Farmington, Connecticut, 06030
United States
University of Miami Sylvester Cancer Center
Miami, Florida, 33136
United States
Orlando Health Cancer Institute
Orlando, Florida, 32806
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Mission Cancer Blood
Waukee, Iowa, 50263
United States
East Jefferson General Hospital Bone Marrow Transport Clinic
Metairie, Louisiana, 70006
United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
United States
Maryland Oncology Hematology P A
Silver Spring, Maryland, 20904
United States
Boston University Medical Center
Boston, Massachusetts, 02118
United States
Saint Lukes Hospital Saint Lukes Cancer Specialists
Chesterfield, Missouri, 63017
United States
Cooper Health System MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, 10032
United States
Durham VAMC
Durham, North Carolina, 27705
United States
Penn Medicine Lancaster General Health
Lancaster, Pennsylvania, 17601
United States
Tennessee Oncology
Nashville, Tennessee, 37203
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
United States
Harris Health Smith Clinic
Houston, Texas, 77054
United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106
United States
Alexander T. Augusta Military Medical Center
Fort Belvoir, Virginia, 22060
United States
Virginia Oncology Associates
Norfolk, Virginia, 23502
United States
NorthWest Medical Specialties, PLLC
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

  • Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-29
Study Completion Date2031-08-31

Study Record Updates

Study Start Date2023-03-29
Study Completion Date2031-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Relapsed or Refractory Multiple Myeloma