ABC294640 in Refractory / Relapsed Multiple Myeloma

This trial is open and accepting eligible patients.

Trial Overview

This is a Phase Ib/II safety and efficacy trial of single agent ABC294640, an inhibitor of sphingosine kinase 2 and dihydroceramide desaturase, in refractory or relapsed multiple myeloma (MM). Cohorts of patients with refractory or relapsed MM who have previously been treated with proteasome inhibitors and immunomodulatory agents will receive increasing doses of oral ABC294640. The starting dosage for ABC294640 will be 250 mg bis in die (BID) which is known to be safely tolerated as a single agent, and the ABC294640 dose will be escalated to two additional dose cohorts of 500 and 750 mg BID using Bayesian model average continual reassessment method (BMA-CRM) for dose finding. It is expected that 18 patients will be used to determine the maximum tolerated dose (MTD) for ABC294640 in refractory or relapsed MM. Up to 56 additional patients will be treated on the phase II portion of the study at the MTD or maximum dose used in phase I, with interim stopping rules for futility. Pharmacokinetic (PK) and pharmacodynamic (PD) assessments of ABC294640 will be conducted on Day 1 of Cycle 1. Bone marrow biopsy will be obtained prior to the initiation of ABC294640, at the end of cycle #3 and at the end of cycle #6. In addition to serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP) and serum free light chain measurement, correlative studies will be performed to measure sphingosine kinase 2 (SK2) activity, sphingosine metabolites, and additional biomarkers in CD138+ myeloma cells.

What is the phase of this trial?

Phase 1/2 what does this mean

What type of trial is this?

This is an interventional trial. This type of trial actively treats your myeloma.

What treatments are used in this trial?
Trial Locations

There are 1 trial site around the United States.
Find the closest trial site or call SparkCures at (888) 828-2206.

How many patients will participate in this trial?

Approximately 74 patients will be enrolled in this study.

Who is sponsoring this trial?

RedHill Biopharma

SparkCures Trial Identifiers

MM-0809 , NCT02757326 what is this

1 US location

Trial Connect

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Am I Eligible For This Trial?

All clinical trials provide reasons that patients may or may not be able to join called 'eligibility criteria'. The following is a high-level eligibility criteria provided by the sponsor of this trial. Additional eligibility criteria may apply.

Trial Contact Information

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Call SparkCures now at (888) 828-2206 and one of our clinical trial specialists will help connect you with the closest trial site. You can also select a trial location below and sign up to have one of our team members contact you.

Trial locations are sorted by state. Enter your zip code to sort by closest distance.

North Carolina

Duke Cancer Center

(Duke University Medical Center)

20 Duke Medicine Circle, Durham, NC 27710

This site is open and accepting eligible patients.

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There is 1 active US location.