Clinical trial NCT00617591
Conditions: Multiple Myeloma
Keywords: Lenalidomide Revlimid Pegylated Liposomal Doxorubicin Doxil Dexamethasone Decadron
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2008-01-01; Completion date: 2013-04-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Detailed 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.

Arms: arm 1: Induction Phase Followed by Maintenance Therapy.

Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.

At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.

Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description.
Interventions: intervention 1: Lenalidomide intervention 2: Pegylated Liposomal Doxorubicin (PLD) intervention 3: Dexamethasone
Intervention descriptions: intervention 1: 25 mg orally on days 1-21 intervention 2: 40 mg/m\^2 intravenously on day 1 (reduced to 30 mg/m\^2 after the initial 29 patients were treated) intervention 3: 40 mg orally on days on 1-4

Protocol documents: