Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00151203

Run by

Weill Medical College of Cornell University

People needed

50

Starts

2004-12-01

Expected to finish

2020-09-29

Last updated by the study team

2021-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Weill Medical College of Cornell University — New York, New York, United States

Full record on ClinicalTrials.gov

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