Administration of Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01374217|
Recruitment Status : Terminated (early stopping rule)
First Posted : June 15, 2011
Results First Posted : December 10, 2018
Last Update Posted : December 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Tadalafil Drug: Lenalidomide Drug: Dexamethasone Drug: Clarithromycin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Administration of an Oral PDE5 Inhibitor, Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma|
|Actual Study Start Date :||April 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Subject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd)
Tadalafil will be administered at a dose of 20 mg orally daily starting with day 1 of the first cycle. Each cycle will last for 28 days
Other Name: Cialis
Lenalidomide will be administered as it was prior to study entry.
Other Name: Revlimid
Dexamethasone will be administered as it was prior to study entry.
Other Name: Decadron
Clarithromycin will be administered as it was prior to study entry.
Other Name: Biaxin
- Response Rate [ Time Frame: Up to 6 months ]Percentage of participants who responded to the addition of tadalafil. Response is defined as a complete remission (CR), very good partial remission (VGPR), partial remission (PR), or stable disease (SD) by International Uniform Response criteria.
- Duration of Response [ Time Frame: Up to 6 months ]Median length of response in months.
- Time to Progression [ Time Frame: Up to 71 days ]Median time to progression of disease in days.
- Quality of Life Scores [ Time Frame: 3 months (M3) and 6 months (M6) ]Median change in symptom scores. Scale is the EORTC QLQ-C30. There are three domains: symptom scale (score range 7-14); past week (score range 21-82); and global health status (score range 2-14). Higher or increasing scores mean worse outcomes; lower or decreasing scores mean better outcomes.
- Effect of PDE5 Inhibition on Immune Function as Assessed by MDSC Quantification [ Time Frame: Up to 6 months ]Percentage change in the amount of myeloid derived suppressor cells (MDSCs) in peripheral blood.
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): NCT01374217
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Nilanjan Ghosh, M.D., Ph.D.||Johns Hopkins University|