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NCT05652335 · ClinicalTrials.gov registry record · Phase 1
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis
A Phase 1 study of Relapsed or Refractory Multiple Myeloma and Previously Treated Amyloid Light-chain (AL) Amyloidosis, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT05652335: Recruiting Phase 1 study of Relapsed or Refractory Multiple Myeloma and Previously Treated Amyloid Light-chain (AL) Amyloidosis, sponsored by Janssen Research & Development.
NCT05652335 is a Phase 1 study of Relapsed or Refractory Multiple Myeloma and Previously Treated Amyloid Light-chain (AL) Amyloidosis that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 180 participants, below the 324-participant average among 10 other Relapsed or Refractory Multiple Myeloma trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05652335, a Phase 1 study of Relapsed or Refractory Multiple Myeloma and Previously Treated Amyloid Light-chain (AL) Amyloidosis, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Conditions Studied
Interventions
- DRUG JNJ-79635322
Study Locations (20)
Other
- UZ Antwerpen - Edegem
- UZ Gent - Ghent
- CHU de Liege - Liège
- CHU Nantes - Nantes
- CHU Lyon Sud - Pierre-Bénite
- Chu Rennes Hopital Pontchaillou - Rennes
- Institut Claudius Regaud - Toulouse
- Japanese Red Cross Medical Center - Shibuya City
- Osaka University Hospital - Suita-shi
- The Cancer Institute Hospital of JFCR - Tokyo
- VUMC Amsterdam - Amsterdam
California
- City of Hope - Duarte
- City of Hope Orange County Lennar Foundation Cancer Center - Irvine
- University of California San Francisco - San Francisco
New York
- Icahn School of Medicine at Mt. Sinai - New York
- Memorial Sloan Kettering Cancer Center - New York
Colorado
- Colorado Blood Cancer Institute - Denver
North Carolina
- Levine Cancer Institute - Charlotte
Pennsylvania
- University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine - Philadelphia
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2022-11-22 |
| Est. Completion | 2028-08-07 |
| Phase | Phase 1 |
What NCT05652335 shows while recruiting
NCT05652335 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 324-participant average among 10 other Relapsed or Refractory Multiple Myeloma trials with a reported enrollment target (44% lower).
The record links to 2 conditions, with Relapsed or Refractory Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which JNJ-79635322 is the first listed.
NCT05652335 names 20 study sites across 7 states, led by Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT05652335 about?
NCT05652335 is a clinical study titled "A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis". 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 expansio...
What is the current status of trial NCT05652335?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2022-11-22. Estimated completion is 2028-08-07.
What conditions does trial NCT05652335 study?
This clinical trial studies the following conditions: Relapsed or Refractory Multiple Myeloma, Previously Treated Amyloid Light-chain (AL) Amyloidosis.
What interventions are being tested in trial NCT05652335?
The interventions under investigation include: JNJ-79635322 (DRUG).
Who is sponsoring clinical trial NCT05652335?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05652335 being conducted?
This trial has 20 study locations across California, Colorado, New York, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05652335's enrollment target sits among peer trials
180 5th of 10 higher than 6 of 10 other Relapsed or Refractory Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Relapsed or Refractory Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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