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

September 6, 2005
December 18, 2009
September 2006
May 2010   (final data collection date for primary outcome measure)
Response rate, time to maximum response, toxicities [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00151203 on ClinicalTrials.gov Archive Site
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Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma
A Phase II Study of Clarithromycin (Biaxin), Lenalidomide (Revlimid), and Dexamethasone (Decadron) for Newly Diagnosed Subjects With Multiple Myeloma

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
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.

Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
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May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00151203
0409007427
Not Provided
Ruben Niesvizky, MD, Weill Cornell Medical College
Weill Medical College of Cornell University
Celgene Corporation
Principal Investigator: Ruben Niesvizky, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP