Clarithromycin,Lenalidomide and Dexamethasone for Relapsed/Refractory Myeloma
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|ClinicalTrials.gov Identifier: NCT02986451|
Recruitment Status : Withdrawn
First Posted : December 8, 2016
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Relapse/Refractory Multiple Myeloma||Drug: clarithromycin Drug: Lenalidomide Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety Study of BiRD (Biaxin [Clarithromycin]/Revlimid [Lenalidomide]/Dexamethasone) Combination Therapy in Relapsed/Refractory Myeloma|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
All patients received clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Dexamethasone (40 mg) was given orally on days 1, 8, 15, and 22. Clarithromycin (500 mg) was given orally twice daily.Lenalidomide (25 mg) was given orally daily on days 1 to 21
Clarithromycin 500mg PO twice daily on days 1-28 for a 28-day cycle.
Other Name: Biaxin
Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle
Other Name: Revlimid
Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle.
Other Name: hexadecadrol
- Overall Response Rate (ORR) [ Time Frame: 30 months ]ORR is defined as the proportion of patients with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment
- Progression Free Survival (PFS) [ Time Frame: 30 months ]PFS, defined as time from first dose of study treatment to progression or death due to any cause, as assessed by investigator
- Overall survival (OS) [ Time Frame: 30 months ]OS, defined as time from first dose of study treatment to death
- Safety of combination therapy assessed using the National Cancer institute-Common Toxicology Criteria (NCI-CTC) grade scale for AEs and Lab assessments [ Time Frame: 30 months ]Safety of combination therapy (Clarithromycin,lenalidomide and dexamethasone) as assessed by toxicity, which will be assessed using the National Cancer Institute-Common Toxicology Criteria (NCI-CTC) grading scale for Adverse Events and for laboratory assessments (v4.03) that include biochemistry, hematology, urinalysis; special safety assessments that include LVEF, Thyroid function Creatinine clearance and ECGs (electrocardiograms).
- Genomic Predictors of Response Rate and PFS [ Time Frame: 30 months ]Blood (about 1-2 tablespoons) collected for biomarker and routine tests and to evaluate the ORR and PFS.
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): NCT02986451
|Sun Yat-sen University Cancer Center|
|GuangZhou, Guangdong, China, 510060|
|Principal Investigator:||zhongjun xia, MD.||hematological oncology department|