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A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05347485
Recruitment Status : Recruiting
First Posted : April 26, 2022
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Cilta-cel Drug: Lymphodepleting Therapy (Cyclophosphamide and Fludarabine) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out-of-Specification (OOS) for Commercial Release in Patients With Multiple Myeloma
Actual Study Start Date : May 13, 2022
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : May 8, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Ciltacabtagene Autoleucel (Cilta-cel)
Eligible participants will receive bridging therapy (that is, anti-plasma cell directed treatment) based on participant's clinical status and timing of availability of cilta-cel (JNJ-68284528) along with lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square [mg/m^2] intravenous [IV] and fludarabine 30 mg/m^2 IV daily, for 3 days). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants will receive a single IV infusion of cilta-cel (JNJ-68284528) at a total targeted dose of 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (cells/kg).
Drug: Cilta-cel
Cilta-cel will be administered as an IV infusion.
Other Name: JNJ-68284528

Drug: Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)
Lymphodepleting therapy (cyclophosphamide and fludarabine) will be administered intravenously.




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Consenting Phase through End of Study (EOS) (Up to 4 years) ]
    ORR is defined as percentage of participants who achieve partial response or better according to international myeloma working group (IMWG) response criteria.


Secondary Outcome Measures :
  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 4 years ]
    Treatment-emergent adverse events (TEAEs) are defined as AEs with onset or worsening on or after date of first dose of study treatment.

  2. Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity [ Time Frame: Up to 4 years ]
    TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE.

  3. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 4 years ]
    SAE is any untoward medical occurrence that results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

  4. Number of Participants with Clinically Significant Abnormalities in Safety Laboratory Tests [ Time Frame: Up to 4 years ]
    Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology, infectious diseases testing, and urinalysis) will be reported.

  5. Number of Participants with Clinically Significant Abnormalities in Vital Signs [ Time Frame: Up to 4 years ]
    Number of participants with clinically significant abnormalities in vital signs (including temperature, pulse/heart rate, respiratory rate, oxygen saturation, and blood pressure) will be reported.

  6. Number of Participants with Clinically Significant Abnormalities in Physical Examination [ Time Frame: Up to 4 years ]
    Number of participants with clinically significant abnormalities in physical examination will be reported.

  7. Partial Response (PR) Rate [ Time Frame: Up to 4 years ]
    PR rate is defined as percentage of participants who achieve PR according to IMWG response criteria.

  8. Very Good Partial Response (VGPR) Rate [ Time Frame: Up to 4 years ]
    VGPR rate is defined as percentage of participants who achieve VGPR according to IMWG response criteria.

  9. Complete Response (CR) Rate [ Time Frame: Up to 4 years ]
    CR rate is defined as percentage of participants who achieve CR according to IMWG response criteria.

  10. Stringent Complete Response (sCR) Rate [ Time Frame: Up to 4 years ]
    sCR rate is defined as percentage of participants who achieve sCR according to IMWG response criteria.

  11. Clinical Benefit Rate (CBR) [ Time Frame: Up to 4 years ]
    CBR (CBR=ORR [sCR+CR+VGPR+PR]+minimal response [MR]) is defined as percentage of participants who achieve CBR according to IMWG response criteria.

  12. Duration of Response (DOR) [ Time Frame: Up to 4 years ]
    DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG response criteria.

  13. Progression Free Survival (PFS) [ Time Frame: Up to 4 years ]
    PFS defined as the time from the date of the initial infusion of cilta-cel out-of-specification (OOS) to the date of first documented disease progression, as defined in the IMWG response criteria, or death due to any cause, whichever occurs first.

  14. Overall Survival (OS) [ Time Frame: Up to 4 years ]
    OS is measured from the date of the initial infusion of cilta-cel OOS to the date of the participant's death. If the participant is alive or the vital status is unknown, then the participant's data will be censored at the date the participant was last known to be alive.

  15. Minimal Residual Disease (MRD) Negative Rate [ Time Frame: Up to 4 years ]
    MRD negative rate is defined as the percentage of participants in CR with negative MRD status.

  16. Number of Participants with Presence of Replication Competent Lentivirus [ Time Frame: Up to 4 years ]
    Number of participants with presence of replication competent lentivirus will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible for treatment with cilta-cel per United States prescribing information (USPI) or locally approved label
  • Participant is suffering from serious or life threatening multiple myeloma per USPI (or locally approved label, respectively), and re-apheresis, re-manufacturing, or other anti-myeloma directed therapies is not considered feasible or adequate per investigator
  • Has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel out-of-specifications (OOS)
  • Meets the criteria to receive lymphodepleting chemotherapy
  • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at consenting and prior to the first dose of cyclophosphamide and fludarabine

Exclusion Criteria:

  • History of active uncontrolled infection or condition where an administration of cilta-cel OOS constitutes serious health risk to the participant
  • Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI
  • Hepatitis B infection
  • Hepatitis C infection defined as (anti hepatitis C virus [HCV] antibody positive or detectable HCV ribonucleic acid [RNA]) or known to have a history of hepatitis C
  • Seropositive for human immunodeficiency virus (HIV)
  • Uncontrolled autoimmune disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05347485


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
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Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
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Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT05347485    
Other Study ID Numbers: CR109014
68284528MMY2005 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Posted: April 26, 2022    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists