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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Celgene Corporation Ortho Biotech Clinical Affairs, L.L.C. |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00617591 |
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.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: Lenalidomide, Pegylated Liposomal Doxorubicin, Dexamethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Pegylated Liposomal Doxorubicin (Doxil®), Low Frequency Dexamethasone and Revlimid® (Dd-R) in Newly Diagnosed Multiple Myeloma |
Estimated Enrollment: | 20 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Induction Phase
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Drug: Lenalidomide, Pegylated Liposomal Doxorubicin, Dexamethasone
The Dd combination regimen will be administered every 28 days as follows:
Oral Lenalidomide (R) will be administered in combination with Dd every 28 days as follows:
All subjects will also receive concommitant amoxicillin 250 mg PO BID (or if allergic receive Ciprofloxacin 250 mg BID), acyclovir 400 mg BID or Valacyclovir 500 mg VID, and aspirin 81 mg PO daily until Dd-R chemotherapy is completed. Aspirin will continue after the chemotherapy portion of the study is complete through maintenance therapy. For patients who cannot tolerate aspirin, low molecular weight heparin or therapeutic doses of coumadin may be used in place of aspirin. |
Induction treatment Cycles 1 - 8 (Each cycle =28 days)
For Cycles 1-8:
Maintenance therapy:
Based on the patient's response to induction therapy, patients may proceed to maintenance therapy which consists of Revlimid® and Dexamethasone. The Revlimid® and Dexamethasone doses will be determined by the doses given during the induction phase. Patients will take Revlimid® by mouth daily for 21 days followed by a 7 days of rest and Dexamethasone by mouth on Days 1-4 of each 28 day cycle. Patients will take an aspirin (81 mg) by mouth daily for 28 days. Patients will receive maintenance therapy until their disease gets worse or they have bad effects.
Procedures and testing for all treatment cycles:
The dose of Revlimid®, Doxil® and/or dexamethasone may be adjusted based on the side effects that may be experienced.
End of Study:
After patients have completed the treatment and maintenance cycles of this study, they will be followed every 3 months to see how they are doing. Patients may be contacted by phone by the study staff if they do not have a regular clinic visit scheduled.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
Contact: Rachid Baz, M.D. | 813-745-3160 | rachid.baz@moffitt.org |
Contact: Kara Kosakowski | 813-745-5758 | kara.kosakowski@moffitt.org |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Rachid Baz, M.D. 813-745-3163 rachid.baz@moffitt.org | |
Contact: Kara Kosakowski 813-745-5758 kara.kosakowski@moffitt.org | |
Principal Investigator: Rachid Baz, M.D. | |
Sub-Investigator: Melissa Alsina, M.D. | |
Sub-Investigator: William S. Dalton, M.D., PhD. | |
Sub-Investigator: Benjamin Djulbegovic, M.D. | |
Sub-Investigator: Dawn Kettner, PA-C | |
Sub-Investigator: Daniel Sullivan, M.D. | |
Sub-Investigator: Darcie Deaver, ARNP | |
Sub-Investigator: Monique Hartley, M.D. | |
Sub-Investigator: John Koomen, Ph.D. | |
Sub-Investigator: Katherine Low, ARNP | |
Sub-Investigator: Sara Tinsley, ARNP |
Principal Investigator: | Rachid Baz, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute ( Mohamad Hussein, M.D. ) |
Study ID Numbers: | MCC-14986, 106095d, RV-MM-PI-107, 07OBCA990185 |
Study First Received: | February 5, 2008 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00617591 History of Changes |
Health Authority: | United States: Institutional Review Board |
Lenalidomide Revlimid Pegylated Liposomal Doxorubicin |
Doxil Dexamethasone Decadron |
Anti-Inflammatory Agents Dexamethasone Blood Protein Disorders Hormone Antagonists Heparin, Low-Molecular-Weight Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Calcium heparin Valacyclovir Anti-Bacterial Agents Ciprofloxacin Hemorrhagic Disorders |
Aspirin Heparin Dexamethasone acetate Amoxicillin Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Lenalidomide Warfarin Glucocorticoids Doxorubicin Multiple Myeloma Acyclovir |
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Antibiotics, Antineoplastic Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Dexamethasone acetate |
Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Gastrointestinal Agents Vascular Diseases Lenalidomide Glucocorticoids Doxorubicin Pharmacologic Actions Multiple Myeloma Neoplasms Autonomic Agents Peripheral Nervous System Agents |