Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I/IIa clinical trial to identify the maximum tolerated dose of atiprimod and to evaluate the safety of atiprimod in patients with refractory or relapsed multiple myeloma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Callisto Pharmaceuticals

Criteria

Inclusion Criteria:

• documented history of multiple myeloma,

• failed at least two prior regimens for multiple myeloma,

• 18 years of age or older,

• ECOG(Zubrod)PS of 0 to 2,

• screening evaluation for determining eligibility prior to enrollment,

• signed informed consent form,

Exclusion Criteria:

• concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma ,

• renal insufficiency (serum creatinine levels of > 2mg/dL),

• mucosal bleeding,

• any condition which in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study.

• clinically relevant active infection or co-morbid medical conditions.

• prior malignancy(within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient is has been disease-free for at least 3 years.

• patients with non-secretory myeloma.

• as atiprimod is a potent inhibitor or CYP2D6, patients taking drugs that are substrates of CYP2D6(e.g. beta blockers, antidepressants and antipsychotics) will be excluded.