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

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00111748
First received: May 24, 2005
Last updated: July 1, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Velcade, Thalidomide, Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: UARK 2005-01, A Phase III Study of Velcade, Thalidomide, and Dexamethasone (VTD) With or Without Adriamycin® in Relapsed/Refractory Patients

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Evaluate the effectiveness of the combination of these drugs [ Time Frame: 168 days ] [ Designated as safety issue: No ]

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 [ Time Frame: 168 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: February 2005
Study Completion Date: September 2006
Arms Assigned Interventions
Active Comparator: 1

Stratification:

  1. CA13/hypodiploidy at diagnosis versus no CA13/hypoploidy at diagnosis
  2. 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

Drug: Velcade, Thalidomide, Dexamethasone

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.

Active Comparator: 2

Stratification:

  1. CA13/hypodiploidy at diagnosis versus no CA13/hypoploidy at diagnosis
  2. 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

Drug: Velcade, Thalidomide, Dexamethasone

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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111748

Locations
United States, Arkansas
University of Arkansas for Medical sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Klaus Hollmig, MD University of Arkansas
  More Information

No publications provided

Responsible Party: Nathan Petty, University_of_Arkansas
ClinicalTrials.gov Identifier: NCT00111748     History of Changes
Other Study ID Numbers: UARK 2005-01
Study First Received: May 24, 2005
Last Updated: July 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arkansas:
Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Liposomal doxorubicin
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antineoplastic Agents

ClinicalTrials.gov processed this record on November 24, 2014