Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma
This trial is active, not recruiting.
|Treatment||clarithromycin, lenalidomide, dexamethasone|
|Sponsor||Weill Medical College of Cornell University|
|Start date||December 2004|
|End date||April 2007|
|Trial size||50 participants|
|Trial identifier||NCT00151203, 0409007427|
PRIMARY STUDY OBJECTIVES
- To evaluate the efficacy of the combination of clarithromycin (Biaxin®), lenalidomide (Revlimid™), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM).
- To evaluate the safety of the combination of clarithromycin, lenalidomide, and dexamethasone as an induction therapy for patients with newly diagnosed MM.
SECONDARY STUDY OBJECTIVES
- To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone and lenalidomide.
- To examine the angiogenesis profile in untreated patients and in patients receiving induction therapy.
|Intervention model||single group assignment|
Response rate, time to maximum response, toxicities
time frame: 3 years
All participants at least 18 years old.
- Subject must voluntarily sign and understand written informed consent.
- Histologically confirmed Durie-Salomon stage II or III MM (see Appendix II). Stage I MM patients will be eligible if they display poor prognostic factors (ß2M > or = 5.5 mg/L, plasma cell proliferation index > or = 5%, albumin of less then 3.0, and unfavorable cytogenetics).
- Measurable disease as defined by > 1.0 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, > 0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s).
- Age > or = 18 years at the time of signing the informed consent form.
- Karnofsky performance status > or = 70% (>60% if due to bony involvement of myeloma (see Appendix V).
- No prior treatment or less than one full course of first-line therapy. Patients may be receiving adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care.
- If the patient is a woman of childbearing age, she must have a negative serum or urine pregnancy test within 7 days of starting study.
- Due to the unknown risk of teratogenic side effects, subjects (women and men) must agree to use effective contraception throughout the duration of the study and for at least 1 month after discontinuation of study drugs.
- Life expectancy > 3 months
- Absolute neutrophil count (ANC)> or = 1000 cells/mm3 (1.0 x 109/L)
- Platelets count > or = 75,000/mm3 (75 x 109/L)
- Serum SGOT/AST < 3.0 x upper limits of normal (ULN)
- Serum SGPT/ALT < 3.0 x upper limits of normal (ULN)
- Serum creatinine < 2.5 mg/dL (221 µmol/L)
- Serum total bilirubin < 2.0 mg/dL (34 µmol/L)
- Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine).
- Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ³ 5 years.
- NYHA Class III or IV heart disease. History of active angina, congestive heart disease, or myocardial infarction within 6 months.
- Pregnant or lactating women are ineligible.
- Known HIV positivity
- Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- Known hypersensitivity to dexamethasone, clarithromycin, lenalidomide, or thalidomide.
- Prior therapy for the treatment of MM
- History of thromboembolic event or other condition currently requiring anticoagulation with warfarin (Coumadin). Patients whose therapy is changed to heparin are eligible.
|Official title||A Phase II Study of Clarithromycin (Biaxin), Lenalidomide (Revlimid), and Dexamethasone (Decadron) for Newly Diagnosed Subjects With Multiple Myeloma|
|Principal investigator||Ruben Niesvizky, MD|
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