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NCT Number: NCT05438043

A Study of Daratumumab

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ZAS Cadix, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be actively receiving daratumumab (either as monotherapy or in combination with other study treatment) in certain Janssen research and development (R&D) studies or receiving other study treatment in a Janssen R&D daratumumab study for participants with multiple myeloma or smoldering multiple myeloma which has reached clinical cutoff for final analysis continue to benefit from study treatment, not have experienced disease progression or unmanageable toxicity while receiving daratumumab, not have met the withdrawal criteria set forth in the parent study, and have had the last dose of study treatment within the previous 3 months
  • Investigator's assessment that the benefit of continued study treatment will outweigh the risks
  • A female participant of childbearing potential must have a negative pregnancy test at screening and must agree to further serum or urine pregnancy tests during the study
  • A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study treatment
  • Must sign an informed consent form (ICF; or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • Willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion criteria

  • Has taken any disallowed therapies or treatment for the disease under study between the completion of the parent study and the planned first dose of study treatment
  • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Known allergies, hypersensitivity, or intolerance to study treatments or their excipients (refer to the daratumumab investigator brochure (IB) and local country prescribing information for dexamethasone, carfilzomib, pomalidomide, and lenalidomide)
  • Vaccinated with an investigational vaccine (except for Coronavirus disease [COVID-19])or live attenuated or replicating viral vector vaccines within 4 weeks prior to enrollment

Treatment and study plan

Daratumumab

Drug

Daratumumab will be administered either intravenously or subcutaneously.

Other names: JNJ-54767414

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.

Primary outcomes

  1. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: 3 years 7 months

    Number of participants with SAEs will be reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.

  2. Number of Participants with AEs of Special Interest (AESI)

    Time frame: 3 years 7 months

    Number of participants with AESI, that is, reactivation of HBV infection, will be reported.

  3. Number of Participants with Pregnancies or Partner Pregnancies

    Time frame: 3 years 7 months

    Number of participants with pregnancies or partner pregnancies will be reported using the appropriate pregnancy notification form.

  4. Number of Participants with Abnormal Pregnancies as SAE

    Time frame: 3 years 7 months

    Number of Participants with Abnormal Pregnancies as SAE will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Jun 29, 2022
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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