NCT01374217

Administration of Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma

Administration of an Oral PDE5 Inhibitor, Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the anti-tumor efficacy of tadalafil in combination with Lenalidomide/dexamethasone (Rd) in multiple myeloma.

Detailed description

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Tadalafil	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
DRUG	Lenalidomide	Lenalidomide will be administered as it was prior to study entry.
DRUG	Dexamethasone	Dexamethasone will be administered as it was prior to study entry.
DRUG	Clarithromycin	Clarithromycin will be administered as it was prior to study entry.

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-06-15
• Last updated: 2018-12-10
• Results posted: 2018-12-10

Locations

1 site across 1 country: United States