Last updated on March 2019

SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma


Brief description of study

A Phase 1/2, Open Label Study of SL-401 in Combination with Pomalidomide and Dexamethasone In Relapsed and Refractory Multiple Myeloma

Detailed Study Description

A Phase 1/2, Open Label Study of SL-401 in Combination with Pomalidomide and Dexamethasone In Relapsed and Refractory Multiple Myeloma.

This study is a Phase 1/2 multi center, open label study of SL-401 in combination with standard doses of Pomalidomide and Dexamethasone. The study will be conducted in 2 Phases: Phase 1 is the dose escalation Phase to determine the MTD or maximum tested dose of SL-401 in combination with standard doses of Pomalidomide and Dexamethasone. In Phase 1, each evaluated SL-401 dose level will incorporate an initial "Run-in Cycle" (i.e. cycle 1) of single agent SL-401 in at least 3 patients; following the Run-in Cycle, patients who have not experienced a DLT will receive combination SL-401/Pomalidomide and Dexamethasone in cycles 2 and beyond. All patients in Phase 2 will initiate therapy with the combination of SL-401/Pomalidomide and Dexamethasone at the maximum tested dose established in Phase 1 in the same manner (i.e. SL-401 alone in cycle 1 followed by combination of SL-401 and Pomalidomide and Dexamethasone in cycles 2 and beyond).

Clinical Study Identifier: NCT02661022

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City of Hope

Duarte, CA United States
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Karmanos

Detroit, MI United States
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Recruitment Status: Open


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