A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT05652335|
Recruitment Status : Recruiting
First Posted : December 15, 2022
Last Update Posted : May 31, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Relapsed or Refractory Multiple Myeloma||Drug: JNJ-79635322||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||November 22, 2022|
|Estimated Primary Completion Date :||April 18, 2025|
|Estimated Study Completion Date :||May 2, 2025|
Experimental: Part 1: Dose Escalation
Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.
JNJ-79635322 will be administered as SC injection.
Experimental: Part 2: Dose Expansion
Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.
JNJ-79635322 will be administered as SC injection.
- Part 1: Number of Participants with Dose-limiting Toxicity (DLT) [ Time Frame: Up to 2 years 5 months ]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 [ Time Frame: Up to 2 years 5 months ]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 [ Time Frame: Up to 2 Years 5 months ]Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.
- Serum Concentration of JNJ-79635322 [ Time Frame: Up to 2 Years 5 months ]Serum samples will be analyzed to determine concentrations of JNJ-79635322.
- Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322 [ Time Frame: Up to 2 Years 5 months ]Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported.
- Preliminary Anticancer Activity of JNJ-79635322 [ Time Frame: Up to 2 Years 5 months ]Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.
- Time to Response (TTR) [ Time Frame: Up to 2 Years 5 months ]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) [ Time Frame: Up to 2 Years 5 months ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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])
- 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)
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): NCT05652335
|Contact: Study Contact||844-434-4210||Participate-In-This-Study@its.jnj.com|
|Edegem, Belgium, 2650|
|Gent, Belgium, 9000|
|CHU de Liège||Recruiting|
|Liege, Belgium, 4000|
|Nantes, France, 44093|
|CHU Lyon Sud||Recruiting|
|Pierre benite, France, 69495|
|Chu Rennes - Hopital Pontchaillou||Recruiting|
|Rennes, France, 35000|
|Institut Claudius Regaud||Recruiting|
|Toulouse, France, 31100|
|Amsterdam, Netherlands, 1081 HV|
|Hosp. Univ. Germans Trias I Pujol||Recruiting|
|Badalona, Spain, 08916|
|Hosp. Clinic I Provincial de Barcelona||Recruiting|
|Barcelona, Spain, 08036|
|Hosp. Univ. Fund. Jimenez Diaz||Recruiting|
|Madrid, Spain, 28040|
|Clinica Univ. de Navarra||Recruiting|
|Pamplona, Spain, 31008|
|Hosp. Clinico Univ. de Salamanca||Recruiting|
|Salamanca, Spain, 37007|
|University College Hospital||Recruiting|
|London, United Kingdom, W1T 7HA|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|
|Responsible Party:||Janssen Research & Development, LLC|
|Other Study ID Numbers:||
2022-001465-12 ( EudraCT Number )
79635322MMY1001 ( Other Identifier: Janssen Research & Development, LLC )
|First Posted:||December 15, 2022 Key Record Dates|
|Last Update Posted:||May 31, 2023|
|Last Verified:||May 2023|
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases