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

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cilta-cel
Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)
Sponsored by
Janssen Scientific Affairs, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 during screening 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

Sites / Locations

  • City of Hope
  • University of California, San Francisco
  • Stanford University Medical Center
  • Colorado Blood Cancer Institute
  • Emory University
  • Northwestern University
  • Kansas University Medical Center
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Barbara Ann Karmanos Cancer Institute
  • Washington University School of Medicine
  • Hackensack University Medical Center
  • Mount Sinai Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Levine Cancer Institute
  • University of Pittsburgh Medical Center
  • MD Anderson Cancer Center
  • Medical College Of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ciltacabtagene Autoleucel (Cilta-cel)

Arm Description

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).

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
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

Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Treatment-emergent adverse events (TEAEs) are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
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.
Number of Participants with Serious Adverse Events (SAEs)
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.
Number of Participants with Adverse Events of Special Interest (AESIs)
Number of participants with AESI will be reported. Cytokine release syndrome, neurotoxicity, prolonged and recurrent cytopenias, and second primary malignancies will be considered to be AESIs.
Number of Participants with Clinically Significant Abnormalities in Safety Laboratory Tests
Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology, infectious diseases testing, and urinalysis) will be reported.
Number of Participants with Clinically Significant Abnormalities in Vital Signs
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.
Number of Participants with Clinically Significant Abnormalities in Physical Examination
Number of participants with clinically significant abnormalities in physical examination will be reported.
Partial Response (PR) Rate
PR rate is defined as percentage of participants who achieve PR according to IMWG response criteria.
Very Good Partial Response (VGPR) Rate
VGPR rate is defined as percentage of participants who achieve VGPR according to IMWG response criteria.
Complete Response (CR) Rate
CR rate is defined as percentage of participants who achieve CR according to IMWG response criteria.
Stringent Complete Response (sCR) Rate
sCR rate is defined as percentage of participants who achieve sCR according to IMWG response criteria.
Clinical Benefit Rate (CBR)
CBR (CBR=ORR [sCR+CR+VGPR+PR]+minimal response [MR]) is defined as percentage of participants who achieve CBR according to IMWG response criteria.
Duration of Response (DOR)
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.
Progression Free Survival (PFS)
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.
Overall Survival (OS)
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.
Minimal Residual Disease (MRD) Negative Rate
MRD negative rate is defined as the percentage of participants in CR with negative MRD status.
Number of Participants with Presence of Replication Competent Lentivirus
Number of participants with presence of replication competent lentivirus will be reported.

Full Information

First Posted
April 21, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Scientific Affairs, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05347485
Brief Title
A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma
Official Title
A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out-of-Specification (OOS) for Commercial Release in Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Scientific Affairs, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ciltacabtagene Autoleucel (Cilta-cel)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Cilta-cel
Other Intervention Name(s)
JNJ-68284528
Intervention Description
Cilta-cel will be administered as an IV infusion.
Intervention Type
Drug
Intervention Name(s)
Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)
Intervention Description
Lymphodepleting therapy (cyclophosphamide and fludarabine) will be administered intravenously.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR is defined as percentage of participants who achieve partial response or better according to international myeloma working group (IMWG) response criteria.
Time Frame
Screening Phase through End of Study (EOS) (Up to 4 years)
Secondary Outcome Measure Information:
Title
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Description
Treatment-emergent adverse events (TEAEs) are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time Frame
Up to 4 years
Title
Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
Description
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.
Time Frame
Up to 4 years
Title
Number of Participants with Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to 4 years
Title
Number of Participants with Adverse Events of Special Interest (AESIs)
Description
Number of participants with AESI will be reported. Cytokine release syndrome, neurotoxicity, prolonged and recurrent cytopenias, and second primary malignancies will be considered to be AESIs.
Time Frame
Up to 4 years
Title
Number of Participants with Clinically Significant Abnormalities in Safety Laboratory Tests
Description
Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology, infectious diseases testing, and urinalysis) will be reported.
Time Frame
Up to 4 years
Title
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Description
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.
Time Frame
Up to 4 years
Title
Number of Participants with Clinically Significant Abnormalities in Physical Examination
Description
Number of participants with clinically significant abnormalities in physical examination will be reported.
Time Frame
Up to 4 years
Title
Partial Response (PR) Rate
Description
PR rate is defined as percentage of participants who achieve PR according to IMWG response criteria.
Time Frame
Up to 4 years
Title
Very Good Partial Response (VGPR) Rate
Description
VGPR rate is defined as percentage of participants who achieve VGPR according to IMWG response criteria.
Time Frame
Up to 4 years
Title
Complete Response (CR) Rate
Description
CR rate is defined as percentage of participants who achieve CR according to IMWG response criteria.
Time Frame
Up to 4 years
Title
Stringent Complete Response (sCR) Rate
Description
sCR rate is defined as percentage of participants who achieve sCR according to IMWG response criteria.
Time Frame
Up to 4 years
Title
Clinical Benefit Rate (CBR)
Description
CBR (CBR=ORR [sCR+CR+VGPR+PR]+minimal response [MR]) is defined as percentage of participants who achieve CBR according to IMWG response criteria.
Time Frame
Up to 4 years
Title
Duration of Response (DOR)
Description
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.
Time Frame
Up to 4 years
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Up to 4 years
Title
Overall Survival (OS)
Description
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.
Time Frame
Up to 4 years
Title
Minimal Residual Disease (MRD) Negative Rate
Description
MRD negative rate is defined as the percentage of participants in CR with negative MRD status.
Time Frame
Up to 4 years
Title
Number of Participants with Presence of Replication Competent Lentivirus
Description
Number of participants with presence of replication competent lentivirus will be reported.
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 during screening 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Scientific Affairs, LLC Clinical Trial
Organizational Affiliation
Janssen Scientific Affairs, LLC
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Kansas University Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical College Of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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