Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: SCRI Development Innovations, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?

Relapsed/refractory Multiple Myeloma (MM) is an incurable disorder with a poor prognosis. Carfilzomib is a novel proteasome inhibitor with activity in this setting. Panobinostat is a pan-deacetylase inhibitor which has shown synergistic cytotoxicity in vitro and in vivo with proteasome inhibitors. The combination should enhance the activity of both agents against myeloma cells. In Phase I, the optimal doses of the combination of carfilzomib and panobinostat will be determined. Assuming this combination is feasible, the Phase II portion will proceed using the doses determined in Phase I.

Eligibility Criteria

Inclusion Criteria

Eligible participants must have multiple myeloma using standard criteria.

Serum M-protein ≥1 g/dl (≥10 g/l)

Urine M-protein ≥200 mg/24 hrs

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Treatment Details

Interventions

Carfilzomib (Proteasome Inhibitor)
Panobinostat (Histone Deacetylase Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Carfilzomib and PanobinostatExperimental Treatment2 Interventions

Phase I: Carfilzomib: cycle 1 - Dose is 20 mg/m\^2 IV on day 1; 27 or 36 or 45 or 56 mg/m\^2 IV on Days 8, 9, 15, 16 cycle 2 to progression - 27 or 36 or 45 or 56 mg/m\^2 IV on days 1, 2, 8, 9, 15, 16 Panobinostat: cycle 1 and cycle 2 to progression - 20 mg or 30 mg on days 1, 3, 5, 15, 17, 19 Phase II: Carfilzomib and Panobinostat: Dose is optimal dose determined in Phase I

Carfilzomib is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Kyprolis for: