Are you or your loved ones suffering from multiple myeloma?

You may be eligible to participate in a multiple myeloma clinical trial.

Are you or your loved ones suffering from multiple myeloma? You may be eligible to participate in a multiple myeloma clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Multiple Myeloma
NCT03492138 | Phase 1 phase 2 | Interventional
Ajai Chari
Sponsored by
Ajai Chari

Are you or your loved ones suffering from multiple myeloma?

You may be eligible to participate in a multiple myeloma clinical trial.

Are you or your loved ones suffering from multiple myeloma? You may be eligible to participate in a multiple myeloma clinical trial.

Recruiting

Male & Female

18 +

years old

This study is looking to recruit 42 Participants

ONC201 is a novel dopamine receptor D2 antagonist that is able to activate the integrated stress response pathway. It is active against multiple myeloma cells in vitro, both as a single agent and in combination with corticosteroids and proteasome inhibitors. In order to document superiority over the combination compared to the individual agents of ixazomib and ONC201 in a single arm study, there will initially be a run-in period of weekly ONC201 625 mg with dexamethasone 40 mg such that if there is progression of disease (25% increase) after 4 weeks or less than a minimal response (25% reduction) after 8 weeks then ixazomib will be added. Dexamethasone is dose-reduced to 20 mg at the same schedule for subjects ≥ 75 years old. If patients do achieve single-agent responses with ONC201 (minimal response or better), they will continue with weekly ONC201 and dexamethasone until progression, with response assessments after each 28-day cycle. Patients who have previously been treated on another clinical trial with weekly ONC201 625mg with dexamethasone with progression while receiving treatment do not need to complete the run-in phase of the study. At the time of progression, they will proceed to the 3 drug combination phase of the study. It is at the point of 3 drug initiation, that below phase I DLT principles or phase II disease control rate considerations apply.

Where you'll go

Selected location

Icahn School of Medicine at Mount Sinai

Icahn School of Medicine at Mount Sinai Change

1 Gustave L. Levy Place, New York, NY, USA 10029

Lisa La, MS 212-241-7873

Map | Learn more
Interested in participating?
Selected location

Icahn School of Medicine at Mount Sinai

1 Gustave L. Levy Place, New York, NY, USA 10029

Lisa La, MS 212-241-7873


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