A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma
This study has been completed.
Information provided by:
CASI Pharmaceuticals, Inc.
First received: December 28, 2007
Last updated: February 25, 2009
Last verified: February 2009
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.
Relapsed Multiple Myeloma
Plateau Phase Multiple Myeloma
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase 2, Open-Label, Safety, and Efficacy Study of 2-Methoxyestradiol Administered to Patients With Plateau Phase or Relapsed Multiple Myeloma
Primary Outcome Measures:
- To determine tumor response of 2ME2 administered orally by evaluation of objective responses in patients with plateau phase or relapsed multiple myeloma [ Time Frame: At least yearly ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess the safety and tolerability of 2ME2 administered orally by evaluation of the frequency, severity, and duration of treatment-emergent adverse events in patients with plateau phase or relapsed multiple myeloma [ Time Frame: As reported ] [ Designated as safety issue: Yes ]
- To determine the minimum 2ME2 levels achieved in plasma following daily oral administration in patients with plateau phase or relapsed multiple myeloma [ Time Frame: At least yearly ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2008 (Final data collection date for primary outcome measure)
Open label, oral administration of 2ME2
800 mg of 2ME2 (capsules) administered orally every 12 hours for a total daily dose of 1600 mg.
Other Name: Panzem
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592579
|Dana Farber Cancer Institute
|Boston, Massachusetts, United States, 02115 |
|Rochester, Minnesota, United States, 55905 |
CASI Pharmaceuticals, Inc.
||Carolyn Sidor, MD, MBA; Chief Medical Officer, EntreMed, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 28, 2007
||February 25, 2009
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs