NCT01133275

Lenalidomide and Prednisone in Low and Int-1 Myelodysplastic Syndrome (MDS) Non 5q MDS

A Phase II Clinical Trial of Lenalidomide and Prednisone in Low and Intermediate-1 IPSS Risk, Non-del (5q) MDS Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to evaluate the use of lenalidomide and prednisone in people with Myelodysplastic Syndrome (MDS). Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the U.S. Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for people with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. As it is being used in this study it is considered an investigational use. An "investigational use" is a use that is being tested and is not approved by the FDA. Prednisone is approved by the FDA to treat numerous conditions. In addition, prednisone is approved by the FDA to treat Low or Intermediate-1 IPSS Risk, non-del (5q) MDS. "Study drug" refers to the combination of lenalidomide and prednisone.

Detailed description

10 mg/day of lenalidomide will be taken by mouth on days 1 - 28 of cycles 1-6. Dosing will be in the morning at approximately the same time each day. Planned prednisone dose: * 30 mg by mouth daily, days 1-28 of cycle 1 * 20 mg by mouth daily, days 1-28 of cycle 2 * 10 mg by mouth daily, days 1-28 of cycle 3 * 10 mg by mouth every other day on days 1-28 of cycles 4-6 * 5 mg by mouth every other day for responders beyond cycle 6

Conditions

• Myelodysplastic Syndrome
• MDS

Interventions

Type	Name	Description
DRUG	Prednisone	Prednisone therapy for 6 cycles (24 weeks).
DRUG	Lenalidomide	Lenalidomide therapy for 6 cycles (24 weeks).

Timeline

• Start date: 2010-04-28
• Primary completion: 2015-01-31
• Completion: 2019-11-21
• First posted: 2010-05-28
• Last updated: 2019-12-17
• Results posted: 2016-01-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study