A Study of Daratumumab

Part of paid clinical trials in Miami, Florida.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05438043
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Daratumumab will be administered either intravenously or subcutaneously.
  • Carfilzomib — DRUG
    Carfilzomib will be administered intravenously.
  • Dexamethasone — DRUG
    Dexamethasone will be administered either orally or intravenously.
  • Lenalidomide — DRUG
    Lenalidomide will be administered orally.
  • Pomalidomide — DRUG
    Pomalidomide will be administered orally.

Study Details

The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R\&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.

Key Dates

Start date
Dec 15, 2022
Status verified
Jun 2026
Primary completion
Jan 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab
    Participants will receive a single dose of daratumumab 16 milligrams per kilograms (mg/kg) intravenous (IV) or 1800 mg subcutaneous (SC) infusion on Cycle 1 Day 1 (28-day cycle), as monotherapy or in combination with standards of care treatment (that is, pomalidomide and dexamethasone, lenalidomide and dexamethasone, carfilzomib and dexamethasone) or standards of care treatment alone, depending on the treatment received in the parent study. Participants who received daratumumab IV during the parent study, will have an option to switch to daratumumab SC on Day 1 of any cycle during this long-term extension study.

Primary Outcome Measure

Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: 3 years 7 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Cancer CenterMiamiFlorida33136-
Emory UniversityAtlantaGeorgia30322-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Barnes-jewish HospitalSt LouisMissouri63108-
Icahn School of Medicine at Mount Sinai - The Derald H. RuttenbergNew YorkNew York10029-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Baylor University Medical CenterDallasTexas75246-

Find similar trials in Miami, FL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Miami Sylvester Cancer Center· Miami, FLEmory University· Atlanta, GAUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MIBarnes-jewish Hospital· St Louis, MOIcahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg· New York, NYMemorial Sloan Kettering Cancer Center· New York, NY

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