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

This study has been terminated.
(early stopping rule)
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01374217
First received: June 13, 2011
Last updated: March 23, 2014
Last verified: March 2014

June 13, 2011
March 23, 2014
August 2011
January 2014   (final data collection date for primary outcome measure)
Anti-tumor efficacy of tadalafil, Lenalidomide/dexamethasone in multiple myeloma [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Hypothesis testing will be used to test the null that 5% patients will have a response versus the alternative hypothesis of 25% (a 20% improvement). If 3 or more out of 19 patients had response, the null hypothesis is rejected at a type I error rate of 0.05 (one-sided) given 20% type II error rate.

If initial review after 12 patients shows at least 1 response, 7 more patients will be enrolled. The therapy will be continued until progression or intolerable adverse effects. Clinical response will be evaluated by calculating the increase or decrease in the M-protein levels in blood and marrow.

Same as current
Complete list of historical versions of study NCT01374217 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Review of the type, frequency, severity, and relationship of adverse events to the study drug
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: Tadalafil, Cialis
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
Experimental: Tadalafil (Cialis)
Subject will take tadalafil(cialis) in combination with with Lenalidomide and dexamethasone (Rd) or Biaxin/Lenalidomide/ dexamethasone (BiRd)
Intervention: Drug: Tadalafil, Cialis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
February 2015
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01374217
J1167, NA_00049238
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Nilanjan Ghosh, M.D., Ph.D. Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP