Study of Velcade and Thalidomide in Patients With Myelodysplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00271804
Recruitment Status : Terminated (New study with lenalidomide pending)
First Posted : January 4, 2006
Last Update Posted : March 13, 2008
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Information provided by:
Massachusetts General Hospital

Brief Summary:
The purpose of this study is to find out what the maximal tolerated dose of Velcade can be given with thalidomide in patients with myelodysplasia.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: bortezomib Phase 1

Detailed Description:

Initial studies using Velcade in myelodysplasia with early results demonstrating that 35% had a partial response and 25% had stable disease. The combination of Velcade and thalidomide has been studied in patients with multiple myeloma, but not in patients with myelodysplasia. The CRR in the MM patients was 22%, with a good safety profile.

This is a phase 1, prospective, open-label, dose escalation study to evaluate the DLT and MTD of velcade with given in combination with thalidomide in patients with myelodysplasia. Treatment will be given as an outpatient. Patients will receive 4 days of Velcade (days 1, 4, 8, 11) and 21 days of thalidomide 50 mg/day for each 21 day cycle. There will be 3 cohorts of 3-6 patients each, plus 10 additional patients. The tree dose levels ill be 0.7, 1.0 and 1.3 mg/m2. Patients may continue to be treated up to 6 cycles. Cycles 2-6 will start within 2 weeks of completion of the previous cycle. Disease response will be evaluated after cycle 3 and 6.

Study Type : Interventional  (Clinical Trial)
Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Dose Escalation Trial of Bortezomib in Combination With Thalidomide in Patients With Myelodysplasia
Study Start Date : June 2005
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The primary objective is to establish the maximally tolerated dose of bortezomib that can be administered with thalidomide in patient with myelodysplasia.

Secondary Outcome Measures :
  1. Assess efficacy in terms of the number of patients attaining a 50% reduction in blast percentage, or 50% reduction in number of red blood cell and/or platelet transfusions.
  2. Determine the toxicity profile of bortezomib when used in combination with thalidomide for patients with myelodysplasia.
  3. Determine the relationship between NF-kB expression and clinical response to bortezomib and thalidomide.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Myelodysplastic syndrome with a IPSS score of 0.5 or greater
  • May have had prior chemo/radiotherapy for another malignancy or myelodysplasia
  • ECOG performance status of 0-2
  • Life expectancy greater than 3 months
  • Total bilirubin </+ 2xULN
  • ALT and AST </+ 3xULN
  • Calculated creatinine clearance > 30 ml/min
  • Use of appropriate method of contraception during the study
  • ANC > 0.5 x 10(9)
  • Platelet count > 30 x 10(9)
  • Consideration of treatment with 5 azacytidine is encouraged by not required

Exclusion Criteria:

  • Ejection fraction < 40%
  • myocardial infarction within 6 months of enrollment of New York Heart Association Class III or IV heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Women who are pregnant or breast-feeding
  • Major surgery within 4 weeks prior to enrollment
  • >/= grade 2 peripheral neuropathy within 14 days prior to enrollment
  • Uncontrolled intercurrent illness
  • Serious medical or psychiatric illness that could potentially interfere with the completion of treatment
  • Hypersensitivity to bortezomib, boron, or mannitol
  • Received an investigational drug within 14 days of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00271804

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Principal Investigator: Karen Ballen, M Massachusetts General Hospital, Harvard University

Responsible Party: Karen Ballen, Massachusetts general Hospital Identifier: NCT00271804     History of Changes
Other Study ID Numbers: 04-381
First Posted: January 4, 2006    Key Record Dates
Last Update Posted: March 13, 2008
Last Verified: March 2008

Keywords provided by Massachusetts General Hospital:
Myelodysplastic syndrome

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors