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A Study of Daratumumab

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05438043
Collaborator
(none)
400
Enrollment
20
Locations
1
Arm
41
Anticipated Duration (Months)
20
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma who are actively receiving daratumumab in a Janssen Research and Development (R&D)-sponsored daratumumab study which has reached clinical cutoff for final analysis and who continue to benefit from study treatment. Certain long-term safety data will continue to be collected from study participants.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Daratumumab activity has been observed in multiple myeloma studies of daratumumab intravenous (IV) and subcutaneous (SC) monotherapy and combination therapy. Daratumumab (JNJ-54767414) is a first-in-class, human Immunoglobulin G1 kappa (IgG1 kappa) monoclonal antibody (mAb) that specifically binds to the cell surface molecule cluster of differentiation 38 (CD38). Daratumumab binds CD38 expressing cells with high affinity in a variety of hematological malignancies, including myeloma, lymphomas, and leukemias, as well as other cell types and tissues with various expression levels, including aberrant plasma cells in systemic light chain amyloid light chain (AL) amyloidosis. This study will provide ongoing access to study treatments for participants with multiple myeloma who are actively receiving daratumumab in a Janssen R&D-sponsored daratumumab study. Participants will continue with the current study treatment dosing regimen established in the parent study. The study will consist of screening phase (up to 6 weeks), treatment phase (28-day cycle) and end of treatment visit 30 days after last dose of study treatment. Safety should be monitored and evaluated according to local institutional standard of care. Safety evaluations and adverse events (AEs) should be documented in the source medical record. Collection of serious adverse events (SAEs), pregnancies, and reports of HBV reactivation will continue until the End of Treatment (EOT) Visit 30 days after the last dose of study treatment or until the start of subsequent anti-cancer therapy, if earlier. The total duration of the study is 3 years 7 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study
Anticipated Study Start Date :
Aug 30, 2022
Anticipated Primary Completion Date :
Jan 30, 2026
Anticipated Study Completion Date :
Jan 30, 2026

Arms and Interventions

Arm Intervention/Treatment
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 (that is, pomalidomide and dexamethasone, lenalidomide and dexamethasone, carfilzomib and dexamethasone), 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.

Drug: Daratumumab
Daratumumab will be administered either intravenously or subcutaneously.
Other Names:
  • JNJ-54767414

    • Drug: Carfilzomib
    Carfilzomib will be administered intravenously.

    Drug: Dexamethasone
    Dexamethasone will be administered either orally or intravenously.

    Drug: Lenalidomide
    Lenalidomide will be administered orally.

    Drug: Pomalidomide
    Pomalidomide will be administered orally.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Serious Adverse Events (SAEs) [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) [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 [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 [3 years 7 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants must be actively receiving daratumumab (either as monotherapy or in combination with other therapy) in a Janssen research and development (R&D)-sponsored daratumumab study for participants with 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 daratumumab within the previous 3 months

    • Investigator's assessment that the benefit of continued daratumumab therapy 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Nantes Nantes Cedex 1 France 44000
    2 Hopital Saint-Louis Paris France 75010
    3 Hôpital Haut-Lévêque Pessac France 33604
    4 CHU Bretonneau Tours Cedex 9 France 37044
    5 Klinikum Chemnitz gGmbH Chemnitz Germany 09113
    6 Asklepios Klinik Altona Hamburg Germany 22763
    7 Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, Tübingen Germany 72076
    8 Pusan National University Hospital Busan Korea, Republic of 49241
    9 Chonnam National University Hwasun Hospital Hwasun Korea, Republic of 519-800
    10 Seoul National University Bundang Hospital Seongnam Korea, Republic of 13620
    11 Samsung Medical Center Seoul Korea, Republic of 06351
    12 Hosp. Univ. Germans Trias I Pujol Badalona Spain 08916
    13 Hosp. Clinic I Provincial de Barcelona Barcelona Spain 08036
    14 Hosp. Gral. Univ. Gregorio Marañon Madrid Spain 28007
    15 Clinica Univ. de Navarra Madrid Spain 28027
    16 Hosp. Univ. Ramon Y Cajal Madrid Spain 28034
    17 Hosp. Univ. 12 de Octubre Madrid Spain 28041
    18 Clinica Univ. de Navarra Pamplona Spain 31008
    19 Hosp. Clinico Univ. de Salamanca Salamanca Spain 37007
    20 Hosp. Univ. Dr. Peset Valencia Spain 46017

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT05438043
    Other Study ID Numbers:
    • CR109200
    • 2021-006494-33
    • 54767414MMY3030
    First Posted:
    Jun 29, 2022
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Dexamethasone
    Lenalidomide
    Daratumumab
    Pomalidomide

    Study Results

    No Results Posted as of Aug 12, 2022