Multiple Myeloma Clinical Trial
Official title:
An Open-Label Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Multiple Myeloma
| NCT number | NCT00096837 |
| Other study ID # | PCYC-0215 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | November 16, 2004 |
| Last updated | June 7, 2006 |
| Verified date | June 2006 |
| Source | Pharmacyclics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of the study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have relapsed or refractory multiple myeloma.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Relapsed or Refractory Multiple Myeloma - = 18 years old - Able to provide consent for participation - ECOG status 0-2 Lab values: - ANC = 1,000/µL - WBC count = 2.0/µL - Hemoglobin = 8.0 g/dL - Platelet count = 50,000/µL - AST and ALT = 2 x ULN - Total Bilirubin = 2 x ULN - Creatinine = 2.0 mg/dL and - Not pregnant or lactating |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Pharmacyclics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of complete response, partial response and stable disease (clinical benefit rate) | |||
| Secondary | Progression-free survival | |||
| Secondary | Safety and tolerability |
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