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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Weill Medical College of Cornell University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00151203
First received: September 6, 2005
Last updated: December 18, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: Clarithromycin, Lenalidomide, Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Response rate, time to maximum response, toxicities [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2006
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151203

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

No publications provided by Weill Medical College of Cornell University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ruben Niesvizky, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00151203     History of Changes
Other Study ID Numbers: 0409007427
Study First Received: September 6, 2005
Last Updated: December 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
newly diagnosed multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Clarithromycin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2014