Trials / Completed
CompletedNCT00182663
Thalidomide, Dexamethasone, and Clarithromycin in Treating Patients With Multiple Myeloma Previously Treated With Transplant
Maintenance Therapy With Thalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 14 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies the side effects and how well giving thalidomide, dexamethasone, and clarithromycin together works in treating patients with multiple myeloma previously treated with transplant. Biological therapies, such as thalidomide and clarithromycin, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone also works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving thalidomide together with dexamethasone and clarithromycin after a transplant may be an effective treatment for multiple myeloma
Detailed description
OBJECTIVES: I. Evaluate the toxicity of the use of Thalidomide/Biaxin (Clarithromycin)/Dexamethasone as maintenance therapy after autologous/syngeneic transplant. II. Evaluate the median time to disease progression. III. Evaluate survival. OUTLINE: Patients receive thalidomide orally (PO) once daily (QD), dexamethasone PO once weekly, and clarithromycin PO twice daily (BID). Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Treatment with thalidomide continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
Conditions
- Refractory Multiple Myeloma
- Stage I Multiple Myeloma
- Stage II Multiple Myeloma
- Stage III Multiple Myeloma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | clarithromycin | Given PO |
| DRUG | thalidomide | Given PO |
| DRUG | dexamethasone | Given PO |
Timeline
- Start date
- 2003-06-01
- Primary completion
- 2007-04-01
- First posted
- 2005-09-16
- Last updated
- 2017-06-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00182663. Inclusion in this directory is not an endorsement.