Phase II Study of Thalidomide, Clarithromycin, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma (T-BiRD)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Weill Medical College of Cornell University.
Recruitment status was: Recruiting
Information provided by:
Weill Medical College of Cornell University
First received: October 2, 2007
Last updated: January 3, 2011
Last verified: January 2011
- Evaluate the efficacy of the combination of thalidomide (Thalomid®), clarithromycin (Biaxin®), lenalidomide (Revlimid®), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM).
- Evaluate the efficacy of the addition of thalidomide (Thalomid®) to BiRD combination therapy as a therapy to increase the complete response rate for patients with newly diagnosed multiple myeloma.
- Evaluate the safety of the combination of clarithromycin, lenalidomide, dexamethasone, and thalidomide as a therapy for patients with newly diagnosed MM
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study of Thalidomide (THALOMID®), Clarithromycin (BIAXIN®), Lenalidomide(REVLIMID®), and Dexamethasone (DECADRON®) for Subjects With Newly Diagnosed Multiple Myeloma
Primary Outcome Measures:
- effect of drug combination on multiple myeloma [ Time Frame: duration of study ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2009 (Final data collection date for primary outcome measure)
• Thalidomide (50mg daily for days 1-7, thereafter 100mg daily for days 8-28 of the first 28 day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 for each subsequent cycle)
• Lenalidomide (25 mg daily days 1-21 of every 28 day cycle)
• Clarithromycin (500mg twice daily for each 28 day cycle)
• Dexamethasone (40 mg daily on day 1, 8, 15 and 22 of each 28 day cycle)
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 ≥ 5 years.
- Myocardial infarction within 6 months prior to enrollment , or NYHA(New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Pregnant or lactating females are ineligible.
- Given the potential of the study drugs to trigger or worsen HIV viremia and the incidence of opportunistic infections inpatients infected with the HIV virus, HIV-1 or HIV-2 positive patients will be excluded. The interactions of HAART with study drugs have not been determined.
- Active hepatitis B or hepatitis C infection.
- Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- Any coexisting medical problem or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial.
- Known hypersensitivity to dexamethasone, clarithromycin, lenalidomide, or thalidomide.
- History of thromboembolic event within the past 6 months prior to enrollment.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00538733
|Weill Medical College of Cornell University
|New York, New York, United States, 10021 |
Weill Medical College of Cornell University
||Ruben Niesvizky, MD
||Weill Medical College of Cornell University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Mark TM, Bowman IA, Rossi AC, Shah M, Rodriguez M, Quinn R, Pearse RN, Zafar F, Pekle K, Jayabalan D, Ely S, Coleman M, Chen-Kiang S, Niesvizky R. Thalidomide, clarithromycin, lenalidomide and dexamethasone therapy in newly diagnosed, symptomatic multiple myeloma. Leuk Lymphoma. 2014 Dec;55(12):2842-9. doi: 10.3109/10428194.2014.896005.
||Ruben Niesvizky, MD, Weill Cornell Medical College
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 2, 2007
||January 3, 2011
||United States: Institutional Review Board
Keywords provided by Weill Medical College of Cornell University:
newly diagnosed multiple myeloma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 07, 2016
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists