Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Aurora, Colorado 80045


Purpose:

This phase II trial studies how well giving bortezomib, lenalidomide, and dexamethasone together works in treating patients with multiple myeloma undergoing stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib, lenalidomide, and dexamethasone together may kill more cancer cells.


Study summary:

CONSOLIDATION: Patients receive bortezomib, lenalidomide, and dexamethasone (VLD) therapy comprising bortezomib intravenously (IV) on days 1, 4, 8, and 11, lenalidomide orally (PO) once daily (QD) on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity. In between courses of VLD, patients receive Lenalidomide + Dexamethasone (LD) therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days. MAINTENANCE: Starting in the third year of therapy, patients receive lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.


Criteria:

Inclusion Criteria: - Patients with symptomatic active multiple myeloma who have completed autotransplant are eligible for the study; patients should be assessed for eligibility within 35 days of the transplant and treatment should commence within 10 weeks of the transplant - Performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria; patients with a poor performance status (3-4) are also eligible, if complications of the bone such as compression fracture, hyperviscosity or infection such as pneumonia have been adequately treated - No significant co-morbid medical conditions; no uncontrolled life threatening infection - Unsupported platelet count > 80,000/uL - Absolute neutrophil count (ANC) > 1000/uL - Signed informed consent should be obtained from all patients in accordance with institutional and federal guidelines Exclusion Criteria: - Patients with a history of recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, difficult to control significant cardiac arrhythmias, or arrhythmia associated with prolonged QT interval - Pregnant or nursing women; women of child-bearing potential must have a negative pregnancy documented within one week of registration; women/men of reproductive potential may not participate unless they have agreed to use two forms of effective contraceptive method - Patients with a grade 3-4 neuropathy related to prior exposure to bortezomib, thalidomide, or other agents - Human immunodeficiency virus (HIV) positive patients - Transaminases > 2 x normal values - Bilirubin > 2 x normal values - Active uncontrolled infection - History of significant psychiatric illness; steroid induced psychosis


Study is Available At:


Original ID:

08-0816.cc


NCT ID:

NCT02353468


Secondary ID:

NCI-2011-03113


Study Acronym:


Brief Title:

Bortezomib, Lenalidomide, and Dexamethasone in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant


Official Title:

Phase II Study: Therapy With Bortezomib + Lenalidomide + Dexamethasone With Lenalidomide + Dexamethasone as Post Transplant Consolidation and Maintenance for Patients With Symptomatic Multiple Myeloma Following Autologous Transplantation


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Principle investigator left the institution


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

3


Enrollment Type:

Actual


Overall Contact Information

Official Name:Choon-kee Lee, MD
Principal Investigator
University of Colorado, Denver

Study Dates

Start Date:December 2009
Completion Date:October 2011
Completion Type:Actual
Primary Completion Date:October 2011
Primary Completion Type:Actual
Verification Date:January 2015
Last Changed Date:January 30, 2015
First Received Date:January 28, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Rate of toxicity
Time Frame:Baseline, and at 3, 6, 9, and 12 months during maintenance therapy
Safety Issues:True
Description:An exact binomial confidence interval will be obtained. Evaluated with the National Cancer Institute Common Terminology for Adverse Events (CTCAE), version 3.0.
Outcome Type:Secondary Outcome
Measure:Quality of life questionnaire while on therapy
Time Frame:up to 5 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Event free survival rates by land-mark analysis
Time Frame:up to 5 years
Safety Issues:False
Description:A Kaplan-Meier curve will be used to describe the distribution.

Study Interventions

Intervention Type:Drug
Name:Bortezomib
Description:Given IV
Arm Name:Enzyme inhibitor, biological therapy, chemothera
Other Name:Velcade
Intervention Type:Drug
Name:Lenalidomide
Description:Given PO
Arm Name:Enzyme inhibitor, biological therapy, chemothera
Other Name:CC-5013
Intervention Type:Drug
Name:Dexamethasone
Description:Given PO or IV
Arm Name:Enzyme inhibitor, biological therapy, chemothera
Other Name:Decadron

Study Arms

Study Arm Type:Experimental
Arm Name:Enzyme inhibitor, biological therapy, chemotherapy
Description:CONSOLIDATION: Patients receive VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity. In between courses of VLD, patients receive LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days. MAINTENANC

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.