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

NCT00573391 | Terminated Phase 3 Results DMC

• 1 other identifier: 2006-05
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

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

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

  24 months

Study Arms (2)

VTD = Velcade, Thal, and Dex

EXPERIMENTAL

VTD = Velcade, Thalidomide, and Dexamethasone

Drug: Velcade, Thalidomide, and Dexamethasone

VMD = velcade, melphalan, and dex

EXPERIMENTAL

VMD = velcade, melphalan, and dexamethasone

Drug: Velcade, Melphalan, and Dexamethasone

Interventions

Velcade, Thalidomide, and Dexamethasone DRUG

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

VTD = Velcade, Thal, and Dex

Velcade, Melphalan, and Dexamethasone DRUG

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

VMD = velcade, melphalan, and dex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• percent 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• Usmani SZ, Sexton R, Hoering A, Heuck CJ, Nair B, Waheed S, Al Sayed Y, Chauhan N, Ahmad N, Atrash S, Petty N, van Rhee F, Crowley J, Barlogie B. Second malignancies in total therapy 2 and 3 for newly diagnosed multiple myeloma: influence of thalidomide and lenalidomide during maintenance. Blood. 2012 Aug 23;120(8):1597-600. doi: 10.1182/blood-2012-04-421883. Epub 2012 Jun 6.

  PMID: 22674807 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Thalidomide; Dexamethasone; Melphalan

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

early termination due to low accrual, no analyses

Results Point of Contact

• Title: Nathan M. Petty
• Organization: University of Arkansas for Medical Sciences, Myeloma Institute

pettynathanm@uams.edu

501-526-6990

Study Officials

• Bart Barlogie, MD, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: August 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 12, 2011
• Results First Posted: August 12, 2011

Record last verified: 2011-07

Locations

US (1)