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

Stopped early · Phase 2

Conditions studied: Multiple Myeloma

In brief

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

Key facts

Study ID

NCT01374217

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

14

Starts

2012-04-01

Expected to finish

2014-01-01

Last updated by the study team

2018-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Progressive myeloma as defined by the International Uniform Criteria.
• Currently on Lenalidomide and dexamethasone for the treatment of myeloma
• Age > 18 years.
• Measurable paraprotein in serum or urine or detectable free light chains in the serum.
• ECOG performance status of 0 - 2.

You may not qualify if…

• Hypersensitivity to PDE5 inhibitors such as tadalafil, sildenafil or vardenafil.
• History of malignancy other than multiple myeloma in the last five years of, except adequately treated basal or squamous cell skin cancer.
• Participation in any clinical trial which involved an investigational drug or device four weeks prior.
• Infection requiring treatment with antibiotics, antifungal, or antiviral agents in the last seven days
• Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
• History of significant hypotensive episode requiring hospitalization.
• Acute myocardial infarction within prior 3 months, uncontrolled angina
• Uncontrolled arrhythmia, or uncontrolled congestive heart failure
• History of any of the following cardiac conditions:
• I. Angina requiring treatment with long-acting nitrates. II. Angina requiring treatment with short-acting nitrates within 90 days of planned tadalafil administration.
• III. Unstable angina within 90 days of visit 1. IV. Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention.
• History of any of the following coronary conditions within 90 days of planned tadalafil administration:
• i. Myocardial Infarction.
• ii. Coronary artery bypass graft surgery.
• iii. Percutaneous coronary intervention (for example, angioplasty or stent placement).
• iv. Any evidence of heart disease (NYHA≥Class III) within 6 months of planned tadalafil administration.
• Current treatment with nitrates.
• Current systemic treatment with a potent cytochrome P450 3A4 (CYP3A4) inhibitors such as ketoconazole or ritonavir.
• Prior chronic immune suppressive state (AIDS, immunosuppressive therapy).
• History of hypotension and/or blindness or sudden decrease/loss of hearing during prior treatment with PDE-5 inhibitors.
• Prior history of non-arterial ischemic optic retinopathy

Where it is running

• Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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