Clinical Trials in Italy / NCT07518186
Recruiting
Phase 3
A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
NCT07518186 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Multiple Myeloma
Investigational drug(s) / intervention(s)
JNJ-79635322: JNJ-79635322 will be administered as SC injection.
Teclistamab: Teclistamab will be administered as SC injection.
Study summary
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
Eligibility
Inclusion criteria:
* Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory
* Received 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation (CD) 38 antibody and lenalidomide
* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the first dose of study medication
* Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment
Exclusion criteria:
* Major surgery, (for example, requiring general anesthesia) or significant traumatic injury within 2 weeks prior to first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
* Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients
* Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; iii. Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM
* Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Primary outcome measure(s)
- Complete Response (CR) or Better — Up to approximately 41 months
CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment. - Progression-Free Survival (PFS) — Up to approximately 41 months
PFS is defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria.
Trial sites (173)
| Facility | City | Region | Status |
|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | Recruiting |
| Mayo Clinic 1 | Phoenix | Arizona | Recruiting |
| Highlands Oncology Group | Springdale | Arkansas | Recruiting |
| Beverly Hills Cancer Center Clinical Research Advisors LLC | Beverly Hills | California | Recruiting |
| UC Irvine Health Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | Recruiting |
| Valkyrie Clinical Trials | Los Angeles | California | Recruiting |
| University of California Irvine Medical Center | Orange | California | Recruiting |
| Colorado Blood Cancer Institute | Denver | Colorado | Recruiting |
| University of Connecticut Health Center | Farmington | Connecticut | Recruiting |
| Mayo Clinic Jacksonville | Jacksonville | Florida | Recruiting |
| Memorial Cancer Institute | Pembroke Pines | Florida | Recruiting |
| Emory University | Atlanta | Georgia | Recruiting |
| Rush University System for Health | Chicago | Illinois | Recruiting |
| Franciscan Health | Indianapolis | Indiana | Recruiting |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | Recruiting |
| Mission Cancer Blood University of Iowa Health Care | Waukee | Iowa | Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | Recruiting |
| LSU Health Feist Weiller Cancer Center | Shreveport | Louisiana | Recruiting |
| Johns Hopkins Hospital | Baltimore | Maryland | Recruiting |
| Tufts Medical Center | Boston | Massachusetts | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| University Of Minnesota Medical Center | Minneapolis | Minnesota | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| Nebraska Cancer Specialists | Omaha | Nebraska | Recruiting |
| Astera Cancer Care | East Brunswick | New Jersey | Recruiting |
| Christus St. Vincent Regional Cancer Center | Santa Fe | New Mexico | Recruiting |
| New York Oncology Hematology | Albany | New York | Recruiting |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island | Mineola | New York | Recruiting |
| NYU Langone Health Manhattan | New York | New York | Recruiting |
| New York Cancer and Blood Specialists | Shirley | New York | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| Gabrail Cancer Center | Canton | Ohio | Recruiting |
| The Christ Hospital | Cincinnati | Ohio | Recruiting |
| Dayton Physicians Network Urology | Dayton | Ohio | Recruiting |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | Recruiting |
| Bon Secours Saint Francis Cancer Center | Greenville | South Carolina | Recruiting |
| Tennessee Oncology, PLLC | Nashville | Tennessee | Recruiting |
| Baylor University Medical Center | Dallas | Texas | Recruiting |
| Joe Arrington Cancer Research Treatment Center | Lubbock | Texas | Recruiting |
| Utah Cancer Specialists | Salt Lake City | Utah | Recruiting |
+ 133 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in Italy
Nipocalimab in Moderate to Severe Sjogren's Disease
Active, not recruiting
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
Active, not recruiting
Other trials for the same condition
Official registry record
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 NCT07518186 on ClinicalTrials.gov ↗ ← All trials in Italy