RecruitingPhase 1NCT06768489

A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma

A Phase 1b Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma


Sponsor

Janssen Research & Development, LLC

Enrollment

140 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe effective dose (recommended Phase 2 doses \[RP2Ds\]) and schedule for JNJ-79635322 treatment regimen in combination with daratumumab with or without lenalidomide or with pomalidomide; and for Part 2 (Dose Expansion) is to further characterize the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing JNJ-79635322 — a new targeted drug — in combination with existing multiple myeloma treatments (daratumumab with or without lenalidomide, or pomalidomide) across different patient groups: newly diagnosed myeloma, earlier relapse, or more heavily pre-treated patients. **You may be eligible if...** - You have been diagnosed with multiple myeloma according to standard criteria - Depending on your treatment group: - Treatment A: You have received 1-3 prior treatment lines including a proteasome inhibitor and an immunomodulatory drug (IMiD), OR you are newly diagnosed with myeloma - Treatment B: You have received at least 1 prior line including a proteasome inhibitor and lenalidomide - Your disease is active and requires treatment **You may NOT be eligible if...** - You have had certain prior therapies that conflict with the study regimen - You have significant kidney, liver, or heart problems that make you ineligible - You have an active infection or uncontrolled health condition - You have had prior severe allergic reactions to the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJNJ-79635322

JNJ-79635322 will be administered subcutaneously.

DRUGDaratumumab

Daratumumab will be administered subcutaneously.

DRUGPomalidomide

Pomalidomide will be administered orally.

DRUGLenalidomide

Lenalidomide will be administered orally.


Locations(14)

Monash Medical Centre

Clayton, Australia

St Vincents Hospital Melbourne

Fitzroy, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Calvary Mater Newcastle Hospital

Waratah, Australia

Wollongong Hospital

Wollongong, Australia

Carmel Medical Center

Haifa, Israel

Hadassah Medical Center

Jerusalem, Israel

Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

VU Medisch Centrum

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

UMC Utrecht

Utrecht, Netherlands

Hosp. Clinic de Barcelona

Barcelona, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

View Full Details on ClinicalTrials.gov

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NCT06768489


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