The primary objective of this study is to evaluate the anti-tumor efficacy of tadalafil in combination with Lenalidomide/dexamethasone (Rd) in multiple myeloma.
This is an early phase study to evaluate the safety and efficacy of the combination of tadalafil with lenalidomide and dexamethasone (Rd) or BiRd. 19 patients on Rd or BiRd will be treated with tadalafil for a minimum of 6 months. The investigational drug will be discontinued if there is evidence of disease progression as defined by the International Uniform Response criteria \[1\]. For responding patients (patients who have a CR, VGPR, PR or SD), the therapy will be continued until progression or intolerable adverse effects. Blood and bone marrow will be collected for various studies as detailed in section 14.10. Clinical response will be monitored every month during the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
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
Lenalidomide will be administered as it was prior to study entry.
Dexamethasone will be administered as it was prior to study entry.
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Response Rate
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.
Time frame: Up to 6 months
Duration of Response
Median length of response in months.
Time frame: Up to 6 months
Time to Progression
Median time to progression of disease in days.
Time frame: Up to 71 days
Quality of Life Scores
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.
Time frame: 3 months (M3) and 6 months (M6)
Effect of PDE5 Inhibition on Immune Function as Assessed by MDSC Quantification
Percentage change in the amount of myeloid derived suppressor cells (MDSCs) in peripheral blood.
Time frame: Up to 6 months
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Clarithromycin will be administered as it was prior to study entry.