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) selected and in disease subgroups in Part 2 (dose expansion).

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

Relapsed or Refractory Multiple Myeloma

Relapsed/ Refractory Multiple Myeloma

Relapsed/Refractory Multiple Myeloma

Relapse Multiple Myeloma

Refractory Multiple Myeloma

Relapsed/Refractory Multiple Myeloma (RRMM)

Multiple Myeloma

Kahler's Disease

Blood Cancer

Hematologic Neoplasms

Hematologic Malignancies

Hematology

Hematological Malignancies

Previously Treated Amyloid Light-chain (AL) Amyloidosis

Amyloidosis

JNJ-79635322

Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated AL Amyloidosis

DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

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.

Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.

Serum samples will be analyzed to determine concentrations of JNJ-79635322.

Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported.

Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.

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 partial response (PR) or better as defined by IMWG 2016 response criteria.

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.

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 International Amyloidosis Consensus Criteria.

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 International Amyloidosis Consensus Criteria or death due to any cause, whichever occurs first.

Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Amyloidosis Consensus Criteria.

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.

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).

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

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.

UZ Antwerpen

UZ Gent

CHU de Liège

CHU Nantes

CHU Lyon Sud

Chu Rennes - Hopital Pontchaillou

Institut Claudius Regaud

VUMC Amsterdam

Hosp. Univ. Germans Trias I Pujol

Hosp. Clinic I Provincial de Barcelona

Hosp. Univ. Fund. Jimenez Diaz

Clinica Univ. de Navarra

Hosp. Clinico Univ. de Salamanca

University College Hospital

Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

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.

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

Trials at a glance

Trials at a glance

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

Outcome measures

Primary outcome measures

Secondary outcome measures