Velcade (Bortezomib), Adriamycin Dexamethasone (PAD) or Vincristine Adriamycin Dexamethasone in Second Line Treatment of Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: adriamycin; bortezomib; dexamethasone; vincristine
Intervention description: adriamycin: 9mg/m² intravenous (IV) push on days 1 to 4; bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle; vincristine: 0.4mg IV push on days 1 to 4
Intervention MeSH terms: Dexamethasone; Vincristine; Doxorubicin; Liposomal doxorubicin; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; bortezomib; Cancer; Hematology; bone marrow; immunoglobulin; relapse; refractory; plasma cell; Velcade; adriamycin; dexamethasone; vincristine

Summary:

      The purpose of this research study is to test the safety and effectiveness of replacing
      vincristine with a drug called bortezomib (also known as "Velcade"or PS341) in the standard
      therapy vincristine, doxorubicin (not limited to, but formerly referred to under the
      tradename Adriamycin) and dexamethasone (VAD) in patients with multiple myeloma. Multiple
      Myeloma is the second most common cancer of the blood. Bortezomib is the first approved
      cancer treatment in a new class of medicines called proteasome inhibitors. It disrupts the
      cell cycle of the cell, affecting numerous biologic pathways, including those related to
      growth and survival of cancer cells. The treatment will be used as second line treatment,
      which means either the disease has returned after a period of improvement (relapse) or the
      disease did not respond to the initial treatment (refractory). Patients will receive either
      bortezomib (PS341), doxorubicin (Adriamycin) and dexamethasone (PAD) or the VAD standard
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsed or refractory multiple myeloma following 1 previous line of therapy and, is
             scheduled by the investigator to be treated with vincristine, adriamycin and
             dexamethasone standard therapy

          -  measurable secretory multiple myeloma based on defined criteria

          -  Karnofsky performance status of >or = 60%

          -  fulfils defined laboratory requirements within 14 days before baseline

          -  if female, the patient is either postmenopausal or surgically sterilised or willing to
             use an acceptable method of birth control for defined period of time

          -  if male, the patient agrees to use an acceptable barrier method for contraception for
             a defined period of time.

        Exclusion Criteria:

          -  More than one previous line of therapy for multiple myeloma

          -  use of bortezomib in the previous line of therapy and/or received bortezomib in a
             previous trial

          -  known allergy or hypersensitivity to bortezomib, boron or mannitol

          -  peripheral neuropathy or neuropathic pain of grade 2 or higher

          -  myocardial infarction within 6 months of enrollment or had New York Heart Association
             (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled
             ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active
             conduction system abnormalities.