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

Study Description

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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

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	December 2004
Actual Primary Completion Date :	April 2007
Estimated Study Completion Date :	August 2022

Arms and Interventions

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Intervention Details:

Drug: Clarithromycin, Lenalidomide, Dexamethasone

Dexamethasone (Decadron®) will be given orally at a dose of 40 mg on days 1, 2, 3, 8, 15 and 22 during the first cycle and once a week on days 1, 8, 15, and 22 for each subsequent cycle.

Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day beginning on day 2 of cycle 1.

Lenalidomide (Revlimid®) will be given orally at a dose of 25 mg daily beginning on day 3 and ending on day 21 of cycle 1 and on days 1-21 of subsequent cycles.

Outcome Measures

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Primary Outcome Measures :

1. Response rate, time to maximum response, toxicities [ Time Frame: 3 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021

Sponsors and Collaborators

Weill Medical College of Cornell University

Celgene Corporation

Investigators

Principal Investigator:	Ruben Niesvizky, MD	Weill Medical College of Cornell University

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rossi A, Mark T, Jayabalan D, Christos P, Zafar F, Pekle K, Pearse R, Chen-Kiang S, Coleman M, Niesvizky R. BiRd (clarithromycin, lenalidomide, dexamethasone): an update on long-term lenalidomide therapy in previously untreated patients with multiple myeloma. Blood. 2013 Mar 14;121(11):1982-5. doi: 10.1182/blood-2012-08-448563. Epub 2013 Jan 8.

Niesvizky R, Jayabalan DS, Christos PJ, Furst JR, Naib T, Ely S, Jalbrzikowski J, Pearse RN, Zafar F, Pekle K, Larow A, Lent R, Mark T, Cho HJ, Shore T, Tepler J, Harpel J, Schuster MW, Mathew S, Leonard JP, Mazumdar M, Chen-Kiang S, Coleman M. BiRD (Biaxin [clarithromycin]/Revlimid [lenalidomide]/dexamethasone) combination therapy results in high complete- and overall-response rates in treatment-naive symptomatic multiple myeloma. Blood. 2008 Feb 1;111(3):1101-9. Epub 2007 Nov 7.

Responsible Party:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00151203 History of Changes
Other Study ID Numbers:	0409007427
First Posted:	September 8, 2005
Last Update Posted:	February 28, 2018
Last Verified:	February 2018

Keywords provided by Weill Medical College of Cornell University:

newly diagnosed multiple myeloma

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Dexamethasone acetate	Dexamethasone; Lenalidomide; Thalidomide; BB 1101; Clarithromycin; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal