A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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 Sweden
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.
View NCT05572515 on ClinicalTrials.gov ↗ ← All trials in Sweden