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