Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00151203|
Recruitment Status : Active, not recruiting
First Posted : September 8, 2005
Last Update Posted : June 4, 2018
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- 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.
- Response rate, time to maximum response, toxicities [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151203
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||Ruben Niesvizky, MD||Weill Medical College of Cornell University|