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

Primary Purpose

Refractory Plasma Cell Myeloma

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Bortezomib

Lenalidomide

Dexamethasone

About this trial

This is an interventional treatment trial for Refractory Plasma Cell Myeloma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Colorado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enzyme inhibitor, biological therapy, chemotherapy

Arm 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. 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.

Outcomes

Primary Outcome Measures

Event Free Survival Rates by Land-mark Analysis

A Kaplan-Meier curve would have been used to describe the distribution.

Secondary Outcome Measures

Full Information

NCT ID

NCT02353468

First Posted

January 28, 2015

Last Updated

February 23, 2015

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT02353468

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Terminated

Why Stopped

Principle investigator left the institution

Study Start Date

December 2009 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Plasma Cell Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Enzyme inhibitor, biological therapy, chemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bortezomib

Other Intervention Name(s)

Velcade

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

CC-5013, CC5013, CDC 501, IMiD-1

Intervention Description

Given PO

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron

Intervention Description

Given PO or IV

Primary Outcome Measure Information:

Title

Event Free Survival Rates by Land-mark Analysis

Description

A Kaplan-Meier curve would have been used to describe the distribution.

Time Frame

up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Choon-kee Lee, MD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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