Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00086216

Run by

Callisto Pharmaceuticals

People needed

30

Starts

2004-05-01

Expected to finish

2007-11-01

Last updated by the study team

2007-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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,

You may not qualify if…

• 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.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.