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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

Phase 3
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

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

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).

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participant Survival With Velcade/Melphalan/Dexamethasone Treatment vs. Participant Survival With Velcade/Thalidomide/Dexamethasone Treatment

Outcome Description:

due to low accrual rates, no analyses was done to compare the new combination of Velcade/Melphalan/Dexamethasone vs. Velcade/Thalidomide/Dexamethasone

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Bart Barlogie, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas


United States: Institutional Review Board

Study ID:




Start Date:

August 2006

Completion Date:

July 2008

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of Arkansas for Medical Sciences Little Rock, Arkansas  72205