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

Running, not enrolling · Phase 3

Conditions studied: Relapsed or Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT05572515

Run by

Janssen Research & Development, LLC

People needed

614

Starts

2023-03-29

Expected to finish

2031-08-31

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Alta Bates Comprehensive Cancer Center — Berkeley, California, United States
• MemorialCare Long Beach Medical Center — Long Beach, California, United States
• University of California Irvine — Orange, California, United States
• PIH Health Hospital — Whittier, California, United States
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States
• University of Connecticut — Farmington, Connecticut, United States
• University of Miami Sylvester Cancer Center — Miami, Florida, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Mission Cancer Blood — Waukee, Iowa, United States
• East Jefferson General Hospital Bone Marrow Transport Clinic — Metairie, Louisiana, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Maryland Oncology Hematology P A — Silver Spring, Maryland, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Saint Lukes Hospital Saint Lukes Cancer Specialists — Chesterfield, Missouri, United States
• Cooper Health System MD Anderson Cancer Center at Cooper — Camden, New Jersey, United States
• Herbert Irving Comprehensive Cancer Center Columbia University Medical Center — New York, New York, United States
• Durham VAMC — Durham, North Carolina, United States
• Penn Medicine Lancaster General Health — Lancaster, Pennsylvania, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Brooke Army Medical Center — Fort Sam Houston, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Michael E DeBakey VA Medical Center — Houston, Texas, United States
• Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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