A Phase 1/2, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 1442 in Patients with Relapsed/Refractory Multiple Myeloma

Clinical Trial Details

This clinical trial is for men and women with relapsed or refractory (return of disease after treatment) multiple myeloma.

The purpose of this study is to see if an experimental drug called ISB 1442 is safe, how much ISB 1442 should be given, how it moves through the body, and how effective it is. Experimental means that ISB 1442 is not yet approved by the U.S. Food and Drug Administration (FDA).

All study participants will need to attend regularly scheduled visits with the study doctor where they will receive the study drug and have other procedures or assessments. The study team will discuss the number of visits required with each individual participant.

Participation is expected to last between 3 to 6 months or longer depending on how the body and disease responds to treatment.

Key Eligibility:

Open to men and women above the age of 18 who have been diagnosed with relapsed/refractory multiple myeloma.
Participants must not have a diagnosis of primary amyloidosis, Waldenström’s disease, monoclonal gammopathy of undetermined significance or smoldering multiple myeloma (SMM), plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), myelodysplastic syndrome, or myeloproliferative syndrome.

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Janiece Francis
646-962-6500
jaf9126@med.cornell.edu

Primary Investigator(s)

Ruben Niesvizky, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2304025912

ClinicalTrials.gov:

NCT05427812

Status

Open to Enrollment

Age Group

Adult

Disease

Multiple Myeloma