A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma

Completed · Phase 2

Conditions studied: Relapsed Multiple Myeloma, Plateau Phase Multiple Myeloma

In brief

The purpose of the study is to determine the safety and effectiveness of providing 2-methoxyestradiol to patients with plateau phase or relapsed multiple myeloma. Information regarding trough 2ME2 levels will also be collected.

Key facts

Study ID: NCT00592579
Run by: CASI pharmaceuticals, Inc.
People needed: 60
Starts: 2001-03-01
Expected to finish: 2008-09-01
Last updated by the study team: 2009-02-26

Who can join

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

You may qualify if…

Have plateau phase (patients who have been previously treated with at least one conventional or high-dose chemotherapy who are currently off all therapy for at least 4 weeks and are considered to have stable disease) or relapsed MM. Patients in plateau phase must have M-protein concentrations that are stable for at least 4 weeks prior to registration.
Be at least 18 years of age.
Have monoclonal plasma cells in the marrow.
have M-protein greater than or equal to 1g/dL in the serum or 200 mg of monoclonal light chain in a 24-hour urine protein electrophoresis.
Have laboratory data as specified below:
AST and ALT < 2.5 x upper limit of normal (ULN)
Alk phos < 5.0 x ULN
direct bilirubin < 2 x ULN
Creatinine < 3.0 x ULN
ANC greater than or equal to 750 cells/mm3
Platelets > 25,000/mm3
Hemoglobin greater than or equal to 7.0g/dL
Have life expectancy of at least 3 months
Have ECOG performance status of 0, 1, or 2
Women and men of child bearing potential must agree to use effective barrier contraceptive methods during study.
Have the ability to understand the reuirements of the study, provide written informed consent, abide to study restrictions, and agree to return for the required assessments.

You may not qualify if…

Be pregnant or nursing.
Have any condition that is likely to detrimentally affect regular follow up.
Have a history of myocardial infarction within the last 3 months, angina pectoris/angina equivalent in the last 3 months, or uncontrolled congestive heart failure.
Have an active infection
Have had major surgery within 21 days of starting 2ME2 administration
Have additional uncontrolled serious medical or psychiatric illness
have had any active cancer in addition to the MM within the last 5 years (excluding superficial skin cancer)
Have uncontrolled or untreated active bleeding or thrombotic disorder.

Where it is running

Dana Farber Cancer Institute — Boston, Massachusetts, United States
Mayo Clinic — Rochester, Minnesota, 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.