Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma
Information source: Weill Medical College of Cornell University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Clarithromycin, Lenalidomide, Dexamethasone (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Weill Medical College of Cornell University Official(s) and/or principal investigator(s):
Ruben Niesvizky, MD, Principal Investigator, Affiliation: Weill Medical College of Cornell University
Summary
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.
Clinical Details
Official title: A Phase II Study of Clarithromycin (Biaxin), Lenalidomide (Revlimid), and Dexamethasone (Decadron) for Newly Diagnosed Subjects With Multiple Myeloma
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Weill Medical College of Cornell University, New York, New York 10021, United States
Additional Information
Starting date: September 2006
Last updated: July 19, 2007
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