Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00287872
Recruitment Status : Completed
First Posted : February 7, 2006
Results First Posted : July 23, 2014
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: bortezomib Drug: thalidomide Phase 2

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VELCADE (Bortezomib) and Thalidomide in Newly Diagnosed Patients With Multiple Myeloma
Study Start Date : September 2004
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Clinical Response to Treatment [ Time Frame: 1-6 months ]
    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: Stringent Complete Response (SCR), CR and normal free light chain ratio and no clonal cells in bone marrow; Complete Response (CR), Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; Very Good Partial Response (VGPR), Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; Partial Response (PR), ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. Objective response is defined as a best overall response of SCR, CR, VGPR, or PR.


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

  2. Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation [ Time Frame: 1-6 months ]
  3. The Time to Response [ Time Frame: 1-6 months ]
  4. Quality of Life [ Time Frame: 0-6 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00287872


Locations
Layout table for location information
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 at Johns Hopkins
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Ivan Borrello, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00287872    
Other Study ID Numbers: J0456 CDR0000450772
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0456
JHOC-04063003
MILLENNIUM-JHOC-J0456
First Posted: February 7, 2006    Key Record Dates
Results First Posted: July 23, 2014
Last Update Posted: March 1, 2018
Last Verified: June 2014
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
stage II multiple myeloma
stage III multiple myeloma
Additional relevant MeSH terms:
Layout table for 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
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