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UARK 2005-01 Study of Velcade, Thalidomide, and Dexamethasone (VTD) With or Without Adriamycin® in Relapsed/Refractory Patients

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Velcade, Thalidomide, Dexamethasone
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma

Eligibility Criteria

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

Inclusion Criteria: Patients with relapsing multiple myeloma (MM) Patients must have adequate platelet count of > 20,000 x 10^9/L, independent of transfusions, unless it is due to massive myeloma infiltration. Anticipated life expectancy of at least 3 months Ejection fraction by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan performed within 60 days prior to registration; left ventricular ejection fraction (LVEF) > 40% by ECHO or MUGA. Female patients of child bearing age are required to have a negative pregnancy test as indicated in thalidomide safety guidelines Patients must have a performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible. All patients must be informed of the investigational nature of this study and must have signed an institutional review board (IRB)-approved informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: Evidence of central nervous system (CNS) involvement Grade > 2 peripheral neuropathy Hypersensitivity to Velcade, boron, or mannitol Recent (< 6 months) myocardial infarction, cerebrovascular accident (CVA)/stroke, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias. Evidence of chronic obstructive or chronic restrictive pulmonary disease. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection. Pregnant or nursing women. Women of child-bearing potential must have a negative pregnancy test documented within one week of registration. Women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study treatment.

Sites / Locations

  • University of Arkansas for Medical sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Stratification: CA13/hypodiploidy at diagnosis versus no CA13/hypoploidy at diagnosis Prior Velcade vs. No prior Velcade TREATMENT:VTD Velcade 1.0 mg/m2 Days 1,4, 8,11 Thalidomide 100 mg Daily qhs Dexamethasone 20 mg Days 1, 2, 4,5, 8, 9, 11, 12 Lovenox 40 mg Days 1-14 Every 21 days

Stratification: CA13/hypodiploidy at diagnosis versus no CA13/hypoploidy at diagnosis Prior Velcade vs. No prior Velcade TREATMENT: VATD Velcade 1.0 mg/m2 Days 1,4, 8,11 Thalidomide 100 mg Daily qhs Dexamethasone 20 mg Days 1, 2, 4,5, 8, 9, 11, 12 Adriamycin 2.5 mg/m2 Days 1-4 & Days 9-12 Lovenox 40 mg Days 1-14 Every 21 days

Outcomes

Primary Outcome Measures

Evaluate the effectiveness of the combination of these drugs

Secondary Outcome Measures

Evaluate the efficacy and toxicity of two treatments in multiple myeloma patients, relapsing after at least one course of high-dose treatment and an autologous stem cell transplant

Full Information

First Posted
May 24, 2005
Last Updated
October 2, 2015
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00111748
Brief Title
UARK 2005-01 Study of Velcade, Thalidomide, and Dexamethasone (VTD) With or Without Adriamycin® in Relapsed/Refractory Patients
Official Title
UARK 2005-01, A Phase III Study of Velcade, Thalidomide, and Dexamethasone (VTD) With or Without Adriamycin® in Relapsed/Refractory Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Arkansas

4. Oversight

5. Study Description

Brief Summary
The main goal of this study is to evaluate the effectiveness of the combination of these drugs, and whether they can be given safely together.
Detailed Description
In this study, there will be two arms (or groups). One arm will receive Velcade, thalidomide, and dexamethasone (VTD), and the other arm will receive VTD with Adriamycin. This study has the following specific goal: To evaluate the efficacy and toxicity of two treatments in multiple myeloma patients, relapsing after at least one course of high-dose treatment and an autologous stem cell transplant, or after at least two lines of conventional chemotherapy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Stratification: CA13/hypodiploidy at diagnosis versus no CA13/hypoploidy at diagnosis Prior Velcade vs. No prior Velcade TREATMENT:VTD Velcade 1.0 mg/m2 Days 1,4, 8,11 Thalidomide 100 mg Daily qhs Dexamethasone 20 mg Days 1, 2, 4,5, 8, 9, 11, 12 Lovenox 40 mg Days 1-14 Every 21 days
Arm Title
2
Arm Type
Active Comparator
Arm Description
Stratification: CA13/hypodiploidy at diagnosis versus no CA13/hypoploidy at diagnosis Prior Velcade vs. No prior Velcade TREATMENT: VATD Velcade 1.0 mg/m2 Days 1,4, 8,11 Thalidomide 100 mg Daily qhs Dexamethasone 20 mg Days 1, 2, 4,5, 8, 9, 11, 12 Adriamycin 2.5 mg/m2 Days 1-4 & Days 9-12 Lovenox 40 mg Days 1-14 Every 21 days
Intervention Type
Drug
Intervention Name(s)
Velcade, Thalidomide, Dexamethasone
Intervention Description
Dosage and Administration Schedule Each cycle will consist of 3 weeks (21 days). AGENT DOSE ROUTE DAYS Velcade 1.0 mg/m2 IV 1, 4, 8, and 11 Thalidomide 100 mg PO Daily, hs Dexamethasone 20 mg PO Days 1, 2, 4,5, 8, 9, 11, 12 Lovenox 40 mg SQ Days 1-14 This 21-day period will be considered one treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). The next cycle of treatment may be delayed up to day 29 due to non-toxicity reasons. Patients may continue to receive treatment every 21 days, provided there is no evidence of disease progression or no unacceptable toxicity for a maximum of eight cycles. At the discretion of the treating physician, patients may be eligible to receive treatment at their local physician after completion of the 1st cycle. These patients will need to return to MIRT prior to every cycle for cycles 2-4, cycles 6 and 8, and final visit.
Primary Outcome Measure Information:
Title
Evaluate the effectiveness of the combination of these drugs
Time Frame
168 days
Secondary Outcome Measure Information:
Title
Evaluate the efficacy and toxicity of two treatments in multiple myeloma patients, relapsing after at least one course of high-dose treatment and an autologous stem cell transplant
Time Frame
168 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with relapsing multiple myeloma (MM) Patients must have adequate platelet count of > 20,000 x 10^9/L, independent of transfusions, unless it is due to massive myeloma infiltration. Anticipated life expectancy of at least 3 months Ejection fraction by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan performed within 60 days prior to registration; left ventricular ejection fraction (LVEF) > 40% by ECHO or MUGA. Female patients of child bearing age are required to have a negative pregnancy test as indicated in thalidomide safety guidelines Patients must have a performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible. All patients must be informed of the investigational nature of this study and must have signed an institutional review board (IRB)-approved informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: Evidence of central nervous system (CNS) involvement Grade > 2 peripheral neuropathy Hypersensitivity to Velcade, boron, or mannitol Recent (< 6 months) myocardial infarction, cerebrovascular accident (CVA)/stroke, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias. Evidence of chronic obstructive or chronic restrictive pulmonary disease. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection. Pregnant or nursing women. Women of child-bearing potential must have a negative pregnancy test documented within one week of registration. Women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Hollmig, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

UARK 2005-01 Study of Velcade, Thalidomide, and Dexamethasone (VTD) With or Without Adriamycin® in Relapsed/Refractory Patients

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