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PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma

This study is ongoing, but not recruiting participants.
Study NCT00049478.   Last updated on November 16, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma
Official Title  An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma Who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After Receiving Dexamethasone in FHCRC Protocol 1746.00
Brief Summary

RATIONALE: PS-341 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known if PS-341 is effective in treating patients who have multiple myeloma.

PURPOSE: Randomized phase III trial to study the effectiveness of PS-341 in treating patients who have refractory or progressive multiple myeloma.

Detailed Description

OBJECTIVES:

  • Determine the time to progressive disease in patients with refractory or progressive multiple myeloma treated with PS-341.
  • Determine the safety and tolerability of this drug in these patients.
  • Determine survival of patients treated with this drug.
  • Determine the rate and duration of response (complete and partial) in patients treated with this drug.
  • Assess the relationship between selected genetic disease markers and response in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

  • Induction therapy: Patients receive PS-341 IV on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 8 courses.
  • Maintenance therapy: Patients receive PS-341 IV on days 1, 8, 15, and 22. Treatment repeats every 5 weeks for up to 3 courses.

Patients who experience progressive disease (PD) after at least 2 courses or no change after at least 4 courses may also receive oral dexamethasone on the day of and the day after PS-341 administration. Patients who experience PD after at least 2 courses of this combined therapy go off study.

Patients are followed at 30 days, every 6 weeks until disease progression, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 1 year.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Open Label
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Multiple Myeloma and Plasma Cell Neoplasm
Intervention  Drug: bortezomib
Drug: dexamethasone
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  July 2002
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma (MM) and meeting 1 of the following criteria:

    • Progressive disease during or after treatment with high-dose dexamethasone on MPI Study M34101-039 (FHCRC-1746.00), with no other antineoplastic treatment for MM initiated
    • Relapsed or progressive disease after receiving at least 4 prior treatment regimens for MM (non-MPI patients)

PATIENT CHARACTERISTICS:

Age

  • Adult

Performance status

  • Karnofsky 60-100% (non-MPI patients)

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 500/mm^3 (no growth factor support)
  • Platelet count at least 20,000/mm^3 (transfusions allowed)
  • Hemoglobin at least 7.0 g/dL (transfusions allowed)

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN
  • Hepatitis B surface antigen negative
  • No known active hepatitis C infection

Renal

  • Calcium less than 14 mg/dL
  • Creatinine clearance at least 20 mL/min

Cardiovascular

  • Non-MPI patients:

    • No myocardial infarction within the past 6 months
    • No New York Heart Association class III or IV heart failure
    • No uncontrolled angina
    • No severe uncontrolled ventricular arrhythmias
    • No acute ischemia or active conduction system abnormalities by EKG
    • No cardiac amyloidosis
    • No poorly controlled hypertension

Other

  • All patients:

    • Not pregnant or nursing
    • Negative pregnancy test
    • Fertile patients must use effective contraception
    • HIV negative
  • Non-MPI patients:

    • No other serious medical or psychiatric illness that would preclude study
    • No prior allergic reaction attributable to compounds containing boron or mannitol
    • No peripheral neuropathy grade 2 or greater
    • No diabetes mellitus
    • No active systemic infection requiring treatment
  • MPI patients:

    • Recovered from dexamethasone-related toxicity
    • No other new or worsening existing illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior immunotherapy or antibody therapy (non-MPI patients)
  • No concurrent thalidomide

Chemotherapy

  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) (non-MPI patients)

Endocrine therapy

  • See Disease Characteristics
  • At least 3 weeks since prior corticosteroids (greater than 10 mg/day of prednisone or equivalent) (non-MPI patients)
  • No other concurrent corticosteroids (e.g., greater than 10 mg/day of prednisone or equivalent)

Radiotherapy

  • Concurrent local short-duration radiotherapy allowed

Surgery

  • At least 4 weeks since prior major surgery (except kyphoplasty) (non-MPI patients)
  • Concurrent kyphoplasty allowed
  • Concurrent emergency orthopedic procedures allowed

Other

  • No other concurrent antineoplastic treatment for MM
  • No other concurrent investigational agents, including commercial agents approved for other indications but investigational for MM
  • No concurrent clarithromycin
  • Concurrent bisphosphonates allowed
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00049478
Organization ID CDR0000258110
Secondary IDs †† MILLENNIUM-M34101-040, FHCRC-1747.00, NCI-G02-2128
Study Sponsor  Millennium Pharmaceuticals, Inc.
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Denise Collins     Millennium Pharmaceuticals, Inc.    
Information Provided By National Cancer Institute (NCI)
Verification Date March 2003
First Received Date  November 12, 2002
Last Updated Date November 16, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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