A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Teclistamab: Teclistamab will be administered subcutaneously.
Pomalidomide: Pomalidomide will be administered orally.
Bortezomib: Bortezomib will be administered subcutaneously.
Dexamethasone: Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.
Carfilzomib: Carfilzomib will be administered intravenously.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Part 1: Progression-free Survival (PFS) — Up to 9 years 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) 2016 response criteria, or death due to any cause, whichever occurs first.
Part 2: Number of Participants Reporting Cytokine Release Syndrome (CRS) Cases by Severity — Up to 9 years Severity for CRS will be graded as follows: Grade 1: Fever (Temperature greater than or equal to \[\>=\] 38°C); Grade 2: Fever (Temperature \>=38°C) with either: hypotension and/or hypoxia requiring low-flow nasal cannula or blow-by; Grade 3: Fever (Temperature \>=38°C) with either: hypotension and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: Fever (Temperature \>=38°C) with either: hypotension requiring multiple vasopressors (excluding vasopressin), and/or hypoxia requiring positive pressure and Grade 5: Death.
Trial sites (211)
Facility
City
Region
Status
Alaska Oncology and Hematology LLC
Anchorage
Alaska
Banner MD Anderson Cancer Center
Gilbert
Arizona
Alta Bates Comprehensive Cancer Center
Berkeley
California
MemorialCare Long Beach Medical Center
Long Beach
California
University of California Irvine
Orange
California
PIH Health Hospital
Whittier
California
Rocky Mountain Cancer Centers
Aurora
Colorado
University of Connecticut
Farmington
Connecticut
University of Miami Sylvester Cancer Center
Miami
Florida
Orlando Health Cancer Institute
Orlando
Florida
Cleveland Clinic Florida
Weston
Florida
Mission Cancer Blood
Waukee
Iowa
East Jefferson General Hospital Bone Marrow Transport Clinic
Metairie
Louisiana
Walter Reed National Military Medical Center
Bethesda
Maryland
Maryland Oncology Hematology P A
Silver Spring
Maryland
Boston University Medical Center
Boston
Massachusetts
Saint Lukes Hospital Saint Lukes Cancer Specialists
Chesterfield
Missouri
Cooper Health System MD Anderson Cancer Center at Cooper
Camden
New Jersey
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York
New York
Durham VAMC
Durham
North Carolina
Penn Medicine Lancaster General Health
Lancaster
Pennsylvania
Tennessee Oncology
Nashville
Tennessee
Brooke Army Medical Center
Fort Sam Houston
Texas
Baylor College of Medicine
Houston
Texas
Michael E DeBakey VA Medical Center
Houston
Texas
Harris Health Smith Clinic
Houston
Texas
Utah Cancer Specialists
Salt Lake City
Utah
Alexander T. Augusta Military Medical Center
Fort Belvoir
Virginia
Virginia Oncology Associates
Norfolk
Virginia
NorthWest Medical Specialties, PLLC
Tacoma
Washington
Blacktown Hospital
Blacktown
Australia
St Vincents Hospital Melbourne
Fitzroy
Australia
Box Hill Hospital
Melbourne
Australia
Fiona Stanley Hospital
Murdoch
Australia
Sir Charles Gairdner Hospital
Nedlands
Australia
LKH - Universitätsklinikum der PMU Salzburg
Salzburg
Austria
Medical University Vienna MUV
Vienna
Austria
Algemeen Ziekenhuis Klina
Brasschaat
Belgium
Jolimont
Haine-St-Paul
Belgium
Az Groeninge
Kortrijk
Belgium
+ 171 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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