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A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma

Primary Purpose

Relapsed or Refractory Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
JNJ-79635322
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

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

Inclusion Criteria: Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria Have relapsed or refractory disease and have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM) Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); or b) Urine M-protein level >=200 milligrams (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio; d) For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (>=2 centimeter [cm]) Exclusion Criteria: Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis Received a cumulative dose of corticosteroids equivalent to greater than (>) 140 mg of prednisone within the 14-day period before the start of study treatment administration Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days) Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration Live, attenuated vaccine within 4 weeks before the first dose of study treatment Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3) The following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, autoimmune disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction <=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, etc)

Sites / Locations

  • UZ AntwerpenRecruiting
  • UZ GentRecruiting
  • CHU de LiègeRecruiting
  • CHU NantesRecruiting
  • CHU Lyon SudRecruiting
  • Chu Rennes - Hopital PontchaillouRecruiting
  • Institut Claudius RegaudRecruiting
  • VUMC AmsterdamRecruiting
  • Hosp. Univ. Germans Trias I PujolRecruiting
  • Hosp. Clinic I Provincial de BarcelonaRecruiting
  • Hosp. Univ. Fund. Jimenez DiazRecruiting
  • Clinica Univ. de NavarraRecruiting
  • Hosp. Clinico Univ. de SalamancaRecruiting
  • University College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1: Dose Escalation

Part 2: Dose Expansion

Arm Description

Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.

Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.

Outcomes

Primary Outcome Measures

Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity
An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. 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 adverse event.
Part 2: Number of Participants with Abnormalities in Laboratory Values
Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.

Secondary Outcome Measures

Serum Concentration of JNJ-79635322
Serum samples will be analyzed to determine concentrations of JNJ-79635322.
Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322
Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported.
Preliminary Anticancer Activity of JNJ-79635322
Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.
Time to Response (TTR)
TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for PR or better as defined by IMWG 2016 response criteria.
Duration of Response (DOR)
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 response criteria, or death due to any cause, whichever occurs first.

Full Information

First Posted
December 7, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05652335
Brief Title
A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
Official Title
Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
April 18, 2025 (Anticipated)
Study Completion Date
May 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

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

5. Study Description

Brief Summary
The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) in Part 2 (dose expansion).
Detailed Description
The study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-79635322 administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as the last study assessment for the last participant on study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
169 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Dose Escalation
Arm Type
Experimental
Arm Description
Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.
Arm Title
Part 2: Dose Expansion
Arm Type
Experimental
Arm Description
Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.
Intervention Type
Drug
Intervention Name(s)
JNJ-79635322
Intervention Description
JNJ-79635322 will be administered as SC injection.
Primary Outcome Measure Information:
Title
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
Description
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Time Frame
Up to 2 years 5 months
Title
Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity
Description
An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. 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 adverse event.
Time Frame
Up to 2 years 5 months
Title
Part 2: Number of Participants with Abnormalities in Laboratory Values
Description
Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.
Time Frame
Up to 2 Years 5 months
Secondary Outcome Measure Information:
Title
Serum Concentration of JNJ-79635322
Description
Serum samples will be analyzed to determine concentrations of JNJ-79635322.
Time Frame
Up to 2 Years 5 months
Title
Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322
Description
Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported.
Time Frame
Up to 2 Years 5 months
Title
Preliminary Anticancer Activity of JNJ-79635322
Description
Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.
Time Frame
Up to 2 Years 5 months
Title
Time to Response (TTR)
Description
TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for PR or better as defined by IMWG 2016 response criteria.
Time Frame
Up to 2 Years 5 months
Title
Duration of Response (DOR)
Description
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 response criteria, or death due to any cause, whichever occurs first.
Time Frame
Up to 2 Years 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria Have relapsed or refractory disease and have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM) Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); or b) Urine M-protein level >=200 milligrams (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio; d) For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (>=2 centimeter [cm]) Exclusion Criteria: Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis Received a cumulative dose of corticosteroids equivalent to greater than (>) 140 mg of prednisone within the 14-day period before the start of study treatment administration Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days) Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration Live, attenuated vaccine within 4 weeks before the first dose of study treatment Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3) The following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, autoimmune disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction <=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, etc)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU de Liège
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Lyon Sud
City
Pierre benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Rennes - Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31100
Country
France
Individual Site Status
Recruiting
Facility Name
VUMC Amsterdam
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Fund. Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
University College Hospital
City
London
ZIP/Postal Code
W1T 7HA
Country
United Kingdom
Individual Site Status
Recruiting

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-79635322 in Participants With Relapsed or Refractory Multiple Myeloma

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