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

NCT01374217 | Terminated Phase 2 Results DMC

• 2 other identifiers: J1167NA_00049238
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 months

Secondary Outcomes (4)

• Duration of Response

  Up to 6 months

• Time to Progression

  Up to 71 days

• Quality of Life Scores

  3 months (M3) and 6 months (M6)

• Effect of PDE5 Inhibition on Immune Function as Assessed by MDSC Quantification

  Up to 6 months

Study Arms (1)

Tadalafil

EXPERIMENTAL

Subject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd)

Drug: Tadalafil; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Clarithromycin

Interventions

Tadalafil DRUG

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

Also known as: Cialis

Tadalafil

Lenalidomide DRUG

Lenalidomide will be administered as it was prior to study entry.

Also known as: Revlimid

Tadalafil

Dexamethasone DRUG

Dexamethasone will be administered as it was prior to study entry.

Also known as: Decadron

Tadalafil

Clarithromycin DRUG

Clarithromycin will be administered as it was prior to study entry.

Also known as: Biaxin

Tadalafil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Tadalafil; Lenalidomide; Dexamethasone; Calcium Dobesilate; Clarithromycin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Isoindoles; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Results Point of Contact

• Title: Nilanjan Ghosh, MD
• Organization: Carolinas HealthCare System

9804422000

Study Officials

• Nilanjan Ghosh, M.D., Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 15, 2011
• Study Start: April 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 10, 2018
• Results First Posted: December 10, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)