Clinical trial · Interventional
A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma
Phase 2, Open-Label, Safety, and Efficacy Study of 2-Methoxyestradiol Administered to Patients With Plateau Phase or Relapsed Multiple Myeloma
NCT00592579CI-TRIAL-00002095completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Plateau Phase Multiple Myeloma | — | UNRESOLVED | — |
| Relapsed Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2-methoxyestradiol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Open label, oral administration of 2ME2
- interventionNames
- Drug: 2-methoxyestradiol
Primary outcomes (1)
- measure
- To determine tumor response of 2ME2 administered orally by evaluation of objective responses in patients with plateau phase or relapsed multiple myeloma
- timeFrame
- At least yearly
Secondary outcomes (2)
- measure
- 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
- timeFrame
- As reported
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTRajkumar SV, Richardson PG, Lacy MQ, Dispenzieri A, Greipp PR, Witzig TE, Schlossman R, Sidor CF, Anderson KC, Gertz MA. Novel therapy with 2-methoxyestradiol for the treatment of relapsed and plateau phase multiple myeloma. Clin Cancer Res. 2007 Oct 15;13(20):6162-7. doi: 10.1158/1078-0432.CCR-07-0807. PMID 17947482