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

CASI Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Relapsed Multiple Myeloma; Plateau Phase Multiple Myeloma

Treatments: Drug: 2-methoxyestradiol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00592579

ME-CL-004

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

2. Be at least 18 years of age.

3. Have monoclonal plasma cells in the marrow.

4. 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.

5. 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

6. Have life expectancy of at least 3 months

7. Have ECOG performance status of 0, 1, or 2

8. Women and men of child bearing potential must agree to use effective barrier contraceptive methods during study.

9. 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.

Exclusion criteria

1. Be pregnant or nursing.
2. Have any condition that is likely to detrimentally affect regular follow up.
3. 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.
4. Have an active infection
5. Have had major surgery within 21 days of starting 2ME2 administration
6. Have additional uncontrolled serious medical or psychiatric illness
7. have had any active cancer in addition to the MM within the last 5 years (excluding superficial skin cancer)
8. Have uncontrolled or untreated active bleeding or thrombotic disorder.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

1

Experimental group

Description:

Open label, oral administration of 2ME2

Treatment:

Drug: 2-methoxyestradiol