Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06768489

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

Led by Janssen Research & Development, LLC · Updated on 2026-05-08

140

Participants Needed

14

Research Sites

207 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria
  • Meet treatment regimen-specific requirements based on prior therapies or newly diagnosed status
  • Have a weight of 40 kilograms or more
  • Have an Eastern Cooperative Oncology Group status of 0 or 2
  • Have measurable disease at screening defined by serum or urine monoclonal protein levels, free light chain levels, or extramedullary disease meeting specific imaging criteria
Not Eligible

You will not qualify if you...

  • Have serious medical conditions such as active infections needing treatment, active autoimmune disease requiring recent immunosuppressive therapy, or significant heart conditions within the last 6 months
  • Received certain prior antitumor therapies within specified time frames before study treatment, including targeted therapy, monoclonal antibodies, gene-modified cell therapy, chemotherapy, proteasome inhibitor or immunomodulatory therapies, and radiotherapy
  • Had stem cell transplantation recently, including allogeneic transplant within 6 months or autologous transplant within 12 weeks before starting study treatment
  • Have unresolved nonhematologic toxicities from prior anticancer therapy except specific exceptions
  • Prior treatment with CD3-redirecting therapy
  • Have medical conditions like pulmonary compromise requiring oxygen, HIV infection, active hepatitis B or C, or recent stroke or seizure within 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Monash Medical Centre

Clayton, Australia, 3168

Actively Recruiting

2

St Vincents Hospital Melbourne

Fitzroy, Australia, 3065

Actively Recruiting

3

Peter MacCallum Cancer Centre

Melbourne, Australia, 3000

Actively Recruiting

4

Calvary Mater Newcastle Hospital

Waratah, Australia, 2298

Actively Recruiting

5

Wollongong Hospital

Wollongong, Australia, 2500

Actively Recruiting

6

Carmel Medical Center

Haifa, Israel, 3436212

Actively Recruiting

7

Hadassah Medical Center

Jerusalem, Israel, 9112001

Actively Recruiting

8

Sheba Medical Center

Ramat Gan, Israel, 52621

Actively Recruiting

9

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Actively Recruiting

10

VU Medisch Centrum

Amsterdam, Netherlands, 1081 HV

Actively Recruiting

11

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

Actively Recruiting

12

UMC Utrecht

Utrecht, Netherlands, 3584 CX

Actively Recruiting

13

Hosp. Clinic de Barcelona

Barcelona, Spain, 08036

Actively Recruiting

14

Hosp Clinico Univ de Salamanca

Salamanca, Spain, 37007

Actively Recruiting

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Research Team

S

Study Contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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