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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT00151203

Collaborator

Celgene Corporation (Industry)

Enrollment

Location

189.9

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Clarithromycin, Lenalidomide, Dexamethasone	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Clarithromycin (Biaxin), Lenalidomide (Revlimid), and Dexamethasone (Decadron) for Newly Diagnosed Subjects With Multiple Myeloma

Actual Study Start Date :

Dec 1, 2004

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Sep 29, 2020

Outcome Measures

Primary Outcome Measures

Response rate, time to maximum response, toxicities [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.