Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00287872
First received: February 6, 2006
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide works in treating patients with newly diagnosed stage II or stage III multiple myeloma.


Condition Intervention Phase
Multiple Myeloma
Drug: bortezomib
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: VELCADE (Bortezomib) and Thalidomide in Newly Diagnosed Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Clinical Response to Treatment [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
    Clinical evaluations of disease response were determined with each cycle. Bone marrow biopsies were done at baseline and at study termination. Clinical responses were defined by the International Myeloma Working Group criteria.


Secondary Outcome Measures:
  • Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher) [ Time Frame: 1-6 months ] [ Designated as safety issue: Yes ]
    Neuropathy was monitored using Total Neuropathy Score reduced (TNSr).

  • Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
  • The Time to Response [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 0-6 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2004
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bortezomib and Thalidomide
The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
Drug: bortezomib
Other Name: VELCADE
Drug: thalidomide

Detailed Description:

OBJECTIVES:

  • Determine the antitumor efficacy of bortezomib and thalidomide in patients with newly diagnosed stage II or III multiple myeloma.
  • Determine the incidence and severity of peripheral motor/sensory neuropathy in patients treated with this regimen.
  • Assess the ability to mobilize and collect stem cells in patients who undergo future autologous peripheral stem cell transplantation.
  • Determine the time to response in patients treated with this regimen.
  • Assess the quality of life of patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses. Patients who plan to undergo transplantation AND achieve ≥ 50% reduction in the tumor burden proceed to transplantation off study. Patients who do not undergo transplantation receive 2 additional courses of therapy beyond best response for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve at least a partial response after completion of treatment may receive maintenance therapy comprising bortezomib IV every 2 months and oral thalidomide* once daily OR twice every 2 months (i.e., the day before and the day of bortezomib administration) in the absence of disease progression or unacceptable toxicity.

NOTE: *For patients who had previously discontinued thalidomide, maintenance therapy may consist of bortezomib only.

Quality of life is assessed at baseline, at the beginning of each study course, and after completion of study treatment.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Newly diagnosed Salmon-Durie stage II or III multiple myeloma

    • Untreated disease OR patient underwent prior therapy for this cancer that lasted no more than 2 weeks
  • Measurable paraprotein in serum or urine (serum free-lite assay measurement allowed)
  • No evidence of cord compression requiring concurrent steroids

PATIENT CHARACTERISTICS:

  • Creatinine clearance ≥ 30 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 methods of contraception, including ≥ 1 highly effective method, 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
  • No known HIV positivity
  • No peripheral neuropathy ≥ grade 2
  • No hypersensitivity to bortezomib, boron, or mannitol

PRIOR CONCURRENT THERAPY:

  • No prior bortezomib
  • More than 28 days since prior regimens with a duration of > 1 week but ≤ 2 weeks
  • No steroids within 14 days prior to study entry
  • No concurrent corticosteroids except for the treatment of a nonmalignant condition

    • May not exceed the equivalent dose of prednisone 10 mg/day
  • No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery
  • No other concurrent investigational agents
  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: NCT00287872

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Ivan Borrello, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00287872     History of Changes
Other Study ID Numbers: J0456 CDR0000450772, P30CA006973, JHOC-J0456, JHOC-04063003, MILLENNIUM-JHOC-J0456
Study First Received: February 6, 2006
Results First Received: June 25, 2014
Last Updated: June 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
stage II multiple myeloma
stage III multiple myeloma

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
Thalidomide
Bortezomib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014