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

Refractory Plasma Cell Myeloma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02353468
• Other study ID #: 08-0816.cc
• Secondary ID: NCI-2011-03113
• Status: Terminated
• Phase: Phase 2
• First received: January 28, 2015
• Last updated: February 23, 2015
• Start date: December 2009
• Est. completion date: October 2011

Study information

• Verified date: January 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Refractory Plasma Cell Myeloma

Intervention

Drug:
• Bortezomib
Given IV
• Lenalidomide
Given PO
• Dexamethasone
Given PO or IV

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free Survival Rates by Land-mark Analysis	A Kaplan-Meier curve would have been used to describe the distribution.	up to 5 years	No