A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis
Condition(s) studied
Investigational drug(s) / intervention(s)
JNJ-79635322: JNJ-79635322 will be administered as SC injection.
Study summary
The primary purpose of this study is to identify the recommended phase 2 dose (RP2D\[s\]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).
Eligibility
Primary outcome measure(s)
- Part 1: Number of Participants with Dose-limiting Toxicity (DLT) — Up to 2 years 5 months
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. - Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity — Up to 2 years 5 months
An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event. - Part 2: Number of Participants with Abnormalities in Laboratory Values — Up to 2 Years 5 months
Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | Recruiting |
| City of Hope Orange County Lennar Foundation Cancer Center | Irvine | California | Recruiting |
| University of California San Francisco | San Francisco | California | Recruiting |
| Colorado Blood Cancer Institute | Denver | Colorado | Recruiting |
| Icahn School of Medicine at Mt. Sinai | New York | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Levine Cancer Institute | Charlotte | North Carolina | Recruiting |
| University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| UZ Antwerpen | Edegem | Belgium | Recruiting |
| UZ Gent | Ghent | Belgium | Recruiting |
| CHU de Liege | Liège | Belgium | Recruiting |
| CHU Nantes | Nantes | France | Recruiting |
| CHU Lyon Sud | Pierre-Bénite | France | Recruiting |
| Chu Rennes Hopital Pontchaillou | Rennes | France | Completed |
| Institut Claudius Regaud | Toulouse | France | Recruiting |
| Japanese Red Cross Medical Center | Shibuya City | Japan | Recruiting |
| Osaka University Hospital | Suita-shi | Japan | Recruiting |
| The Cancer Institute Hospital of JFCR | Tokyo | Japan | Completed |
| VUMC Amsterdam | Amsterdam | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | Recruiting |
| UMC Utrecht | Utrecht | Netherlands | Recruiting |
| Hosp. Univ. Germans Trias I Pujol | Badalona | Spain | Recruiting |
| Hosp Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Hosp Univ Fund Jimenez Diaz | Madrid | Spain | Recruiting |
| Clinica Univ. de Navarra | Pamplona | Spain | Recruiting |
| Hosp Clinico Univ de Salamanca | Salamanca | Spain | Recruiting |
| University College Hospital | London | United Kingdom | Recruiting |
| Royal Marsden Hospital | Sutton | United Kingdom | Recruiting |
More Janssen Research & Development, LLC trials in Spain
Other trials for the same condition
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 NCT05652335 on ClinicalTrials.gov ↗ ← All trials in Spain