Study of Multiple Myeloma Patients Relapsing or Progressing After Autologous Transplantation on Total Therapy 2

This study has been terminated.
(low accrual)
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00573391
First received: December 12, 2007
Last updated: July 18, 2011
Last verified: July 2011
  Purpose

This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study for Patients Relapsing or Progressing After Autologous Transplantation on Total Therapy 2 (TT2, UARK 98-026): Bortezomib, Thalidomide and Dexamethasone Versus Bortezomib, Melphalan, and Dexamethasone

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Participant Survival With Velcade/Melphalan/Dexamethasone Treatment vs. Participant Survival With Velcade/Thalidomide/Dexamethasone Treatment [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    due to low accrual rates, no analyses was done to compare the new combination of Velcade/Melphalan/Dexamethasone vs. Velcade/Thalidomide/Dexamethasone


Enrollment: 5
Study Start Date: August 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VTD = Velcade, Thal, and Dex
VTD = Velcade, Thalidomide, and Dexamethasone
Drug: Velcade, Thalidomide, and Dexamethasone

Velcade - Into vein (IV) Days 1, 4, 8, 11

Yr 1: Every 28-35 days-12 cycles

Yr 2: Every 8-10 weeks- 6 cycles

Thalidomide - By Mouth Days 1-28

Yr 1: Every 28-35 days-12 cycles

Yr 2: Every 8-10 weeks- 6 cycles

Experimental: VMD = velcade, melphalan, and dex
VMD = velcade, melphalan, and dexamethasone
Drug: Velcade, Melphalan, and Dexamethasone

Velcade - Into vein (IV) Days 1, 4, 8, 11

Yr 1: Every 28-35 days-12 cycles

Yr 2: Every 8-10 weeks- 6 cycles


Detailed Description:

A new drug (bortezomib [VelcadeTM PS-341]) has been shown in recent studies to be effective in subjects with advanced multiple myeloma. There is also research that shows this drug may be even more effective when used in combination with other drugs that have been used to treat myeloma for many years (melphalan, thalidomide, and dexamethasone). This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of histologically documented MM previously enrolled on UARK 98-026 with relapsed or progressive disease after at least one autologous transplant.
  • Patient has measurable disease in which to capture response, defined as:
  • Serum M-protein level > 1.0 gm/dl (10.0 g/L) measured by serum protein electrophoresis or immunoglobulin electrophoresis
  • Urinary M-protein excretion > 200 mg/24 hrs
  • Bone marrow plasmacytosis of > 30percent by bone marrow aspirate and/or biopsy
  • Serum Free Light Chains (By the Freelite test) > 10 mg/dL with an abnormal kappa/lambda ration.
  • 50percent increase in size of lytic and/or focal lesions or development of new lesions recognized by radiographic studies.
  • Performance status of 2 as per SWOG scale, unless PS of 3-4 based solely on bone pain.
  • Patients must have a platelet count 50,000/mm3, unless the low platelet count is due to documented (>30 percent) extensive myeloma infiltration of the bone marrow.
  • Patients must have adequate renal function defined as serum creatinine < 2.5 mg/dl.
  • Patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 2 x the upper limit of normal.
  • Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
  • Male or female adults of at least 18 years of age.
  • Patients must have signed and IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations
  • > 5 x 106 CD34 cells/kg in storage strongly desired, but not mandated

Exclusion Criteria:

  • Not previously enrolled on UARK 98-026.
  • Has received salvage therapy after coming off UARK 98-026.
  • Evidence of POEMS Syndrome..
  • Significant neurotoxicity interfering with ADL.
  • Platelet count < 50,000/mm3
  • Clinically significant hepatic dysfunction as noted by bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis.
  • New York Hospital Association (NYHA) Class III or Class IV heart failure.
  • Myocardial infarction within the last 6 months.
  • Truly non-secretory MM (no increase in serum free-light chains) in the absence of bone marrow plasmacytosis and MRI-defined focal lesions with CT-FNA-proven MM
  • Uncontrolled, active infection requiring IV antibiotics.
  • Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
  • Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
  • Pregnant or potential for pregnancy. Women of childbearing potential will have a pregnancy test at screening, and will be required to use a medically approved contraceptive method. Pregnancy testing will be performed prior to administration of each dose of study drug.
  • Breast-feeding women may not participate.
  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: NCT00573391

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: Bart Barlogie, MD, PhD University of Arkansas
  More Information

No publications provided by University of Arkansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bart Barlogie, MD, PhD, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00573391     History of Changes
Other Study ID Numbers: 2006-05
Study First Received: December 12, 2007
Results First Received: April 15, 2011
Last Updated: July 18, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
Melphalan
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 28, 2014