Dose Escalation Study of JNJ-64407564 in Participants With Relapsed or Refractory Multiple Myeloma

Overview

The purpose of this study is to characterize the safety of JNJ-64407564 and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for JNJ-64407564 (Part 1 [Dose Escalation]) and to further characterize the safety of JNJ-64407564 at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]).

The study will be conducted in 2 parts, separately for intravenous (IV) and subcutaneous (SC) administration: dose escalation and dose expansion. The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-64407564 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 in the study.

SparkCures ID 938
Trial Phase Phase 1
Enrollment 185 Patients
Treatments
Trial Sponsors
  • Janssen Research & Development
NCT Identifier

NCT03399799

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Participants with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine
  • Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease

Exclusion Criteria:

  • Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of JNJ-64407564
  • Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( ≥) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug
  • Stem cell transplantation: Previously received an allogenic stem cell transplant; and/or received an autologous stem cell transplant less than or equal to (<=) 12 weeks before the first dose of study drug
  • Documented history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, whole body magnetic resonance imaging (MRI) and lumbar cytology are required

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

California
New York
Tennessee

Resources

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