Pegylated Liposomal Doxorubicin, Low Freq Dexamethasone & Revlimid (Dd-R) in Newly Diagnosed Multiple Myeloma (MM)

Multiple Myeloma Clinical Trial

Official title: Phase II Study of Pegylated Liposomal Doxorubicin (Doxil®), Low Frequency Dexamethasone and Revlimid® (Dd-R) in Newly Diagnosed Multiple Myeloma

Status Completed

Clinical Trial Summary

The purpose of the research study is to determine the response rates when Revlimid® is combined with Doxil® and Dexamethasone (Dd-R) in newly diagnosed Multiple Myeloma. The study will also evaluate the side effects caused by the combination of these three drugs. This therapy is investigational in the treatment of Multiple Myeloma.

Revlimid® 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. Revlimid® is approved by the Food and Drug Administration (FDA) for specific types of myelodysplastic syndrome (MDS) and Multiple Myeloma, two different types of blood cancer. It is currently being tested in a variety of other cancer conditions. In this case it is considered experimental.

Doxil® is a form of chemotherapy. It is approved by the FDA for the treatment of relapsed/ refractory Multiple Myeloma in combination with Velcade.

Dexamethasone is a steroid. It is also approved by the FDA, but not for the treatment of Multiple Myeloma. It is considered a standard part of most myeloma therapies for newly diagnosed patients.

Clinical Trial Description

Induction Phase:

Newly diagnosed multiple myeloma patients with active disease, will be treated with Dd-R as outlined below:

All patients will also receive Levaquin 500 mg by mouth (PO) every day (QD) [or if allergic receive amoxicillin 250 mg PO twice a day (BID)], acyclovir 400 mg PO BID or Valacyclovir 500 mg BID and aspirin 81 mg PO QD daily while receiving Dd-R. Aspirin will continue through maintenance. For patients who cannot tolerate aspirin, low molecular weight heparin or therapeutic doses of coumadin may be used in place of aspirin.

• Doxil® 30 mg/m^2 on day # 1 to be repeated every 28 days

• Dexamethasone 40 mg per day for 4 days (days 1-4) every 28 days

• Revlimid® 25 mg PO daily on days 1-21, followed by 7 days of no therapy, repeated every 28 days

Maintenance Therapy:

Patients who complete the induction regimen or those who complete at least 2 cycles of the induction regimen and not showing evidence of progressive disease but cannot tolerate any further chemotherapy could be started on maintenance therapy as follows:

• Revlimid® 15 mg or 25 mg* PO daily on days 1-21, followed by 7 days of no therapy, repeated every 28 days

Patients will start maintenance therapy at the dexamethasone dose that was tolerated at the completion of the induction phase. *The starting Revlimid® dose for maintenance will be either 15 mg or 25 mg, which will be determined based on whether specific criteria are met on scheduled Day 1.

• Dexamethasone 40 mg per day for 4 days (days 1-4) every 28 days

All participants will also receive aspirin 81 mg PO QD daily while receiving maintenance. For patients who cannot tolerate aspirin, low molecular weight heparin or therapeutic doses of coumadin may be used in place of aspirin. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

• NCT number: NCT00617591
• Study type: Interventional
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Status: Completed
• Phase: Phase 2
• Start date: January 2008
• Completion date: April 2013