NL-OMON53500
Not yet recruiting
Not Applicable
Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants with Relapsed or Refractory Multiple Myeloma - 79635322MMY1001
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Janssen-Cilag
- Enrollment
- 12
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) \>\=18 years of age (or the legal age of consent in the jurisdiction in
- •which the study is taking place) at the time of informed consent.
- •2\) Have documented initial diagnosis of multiple myeloma according to
- •IMWG diagnostic criteria (Appendix 10\.9\)
- •3\) Have relapsed or refractory disease and have been treated with a
- •proteasome inhibitor, IMiD agent, and an anti\-CD38\-based therapy for
- •the treatment of MM
- •4\) Have measurable disease at screening as defined by at least 1 of the
- •a. Serum M\-protein level \>\=0\.5 g/dL; or
- •b. Urine M\-protein level \>\=200 mg/24 hours; or
Exclusion Criteria
- •1\) Central nervous system involvement or clinical signs of meningeal
- •involvement of multiple myeloma. If either is suspected, whole brain
- •MRI and lumbar cytology are required during screening
- •2\) Active plasma cell leukemia, Waldenström's macroglobulinemia,
- •POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, Mprotein,
- •and skin changes), or primary light chain amyloidosis.
- •3\) Pulmonary compromise requiring supplemental oxygen used to
- •maintain adequate oxygenation
- •4\) Any serious underlying medical conditions, such as:
- •a. Evidence of active viral, bacterial, or systemic
Outcomes
Primary Outcomes
Not specified
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