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