Trials / Completed
CompletedNCT00619684
Lenalidomide in Treating Patients With Progressive or Recurrent Multiple Myeloma After a Donor Stem Cell Transplant
A Phase II Study of Lenalidomide Following Allogeneic Stem Cell Transplant for Multiple Myeloma Patients Who Relapse or Have Disease Progression
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well lenalidomide works in treating patients with progressive or recurrent multiple myeloma after a donor stem cell transplant. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate response of relapsed or progressive multiple myeloma to lenalidomide after allogeneic stem cell transplant. II. Proportion of patients achieving a complete, partial or minor response. SECONDARY OBJECTIVES: I. Evaluate toxicity and tolerability of lenalidomide in this setting. II. For patients with chronic graft-versus-host disease (GVHD), evaluate the response to lenalidomide. III. Evaluate time to progression (TTP). IV. Evaluate overall survival (OS). OUTLINE: Patients receive lenalidomide orally (PO) on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
Conditions
- Refractory Multiple Myeloma
- Stage I Multiple Myeloma
- Stage II Multiple Myeloma
- Stage III Multiple Myeloma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lenalidomide | Given PO |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2015-08-01
- Completion
- 2015-09-01
- First posted
- 2008-02-21
- Last updated
- 2017-05-18
- Results posted
- 2017-04-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00619684. Inclusion in this directory is not an endorsement.