This trial is active, not recruiting.

Condition multiple myeloma
Treatment clarithromycin, lenalidomide, dexamethasone
Phase phase 2
Sponsor Weill Medical College of Cornell University
Collaborator Celgene Corporation
Start date September 2006
End date May 2010
Trial size 50 participants
Trial identifier NCT00151203, 0409007427



- 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.


- 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Response rate, time to maximum response, toxicities
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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) Exclusion Criteria: - 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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.