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

• Status: Completed
• Trial end date: 2020-09-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Celgene Corporation
• Treatments: BB 1101; Clarithromycin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

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.