A Pilot Study of the Combination of Melphalan, Bortezomib, Thalidomide and Dexamethasone (MEL-VTD)

NCT00577668 | Withdrawn Phase 2

• 1 other identifier: 2007-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, researchers want to find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be given safely to subjects who have failed previous transplant(s).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• VTD regimen with melphalan

  To find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be given safely to subjects who have failed previous transplant(s).

  12 months

Study Arms (1)

VDT and Melphalan

EXPERIMENTAL

To find out if three drugs, bortezomib, thalidomide, and dexamethasone in addition to high doses of melphalan (M-VTD) and autologous transplant can be given safely and effectively to subjects who have failed previous regimens with transplant(s).

Drug: Melphalan, Velcade, Thalidomide, Dexamethasone

Interventions

Melphalan, Velcade, Thalidomide, Dexamethasone DRUG

To assess, in patients with one or two prior auto transplants, the efficacy of a high-dose combination chemotherapy with MEL 300 (in 3 fractions of 100 mg/m2 on days -7, -4, -1) plus VTD (Velcade = bortezomib 1.3 mg/m2 on days -7, -4, -1; Thalidomide 200 mg/d on days -1 through -7; Dexamethasone 40 mg on days -7, -6, -4, -3, -1, 0) followed by autologous peripheral blood stem cell (PBSC) infusion of a minimum dose of 3 million CD34 cells/kg.

VDT and Melphalan

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 with relapsed or progressive disease after either scheduled tandem or one autologous transplantation.
• Patient has measurable disease in which to capture response.
• Performance status of 2 as per Zubroid scale, unless PS of 3-4 based solely on bone pain.
• Patients must have a platelet count 75,000/μL, and an ANC of at least 1,000/μL.
• 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 an IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations.

You may not qualify if:

• Chemotherapy or radiotherapy received within the previous 2 weeks.
• Significant neurotoxicity, defined as grade \> 2 neurotoxicity per NCI Common Toxicity Criteria (See Appendix).
• Platelet count \< 75,000/mm3, or ANC \< 1,000/μl.
• 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.
• 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.
• 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

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Melphalan; Bortezomib; Thalidomide; Dexamethasone

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)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; 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

Study Officials

• Mauricio Pineda-Roman, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: April 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 3, 2011

Record last verified: 2011-05

Locations

US (1)