A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Doxil; Thalidomide; Dexamethasone
Intervention description: Doxil 40 mg/m2 IV day 1; 50-100 mg day 1-28; Dexamethasone 40 mg day 1-4 and 15-18
Intervention MeSH terms: Thalidomide; Dexamethasone; Doxorubicin; Liposomal doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Four monthly treatments with pegylated liposomal doxorubicin, thalidomide and dexamethasone
      for newly diagnosed myeloma patients as induction therapy prior to high dose chemotherapy and
      autologous stem cell transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with active, symptomatic multiple myeloma without prior chemotherapy:

          -  Durie-Salmon Stage II-III A/B

          -  Stage I patients with at least 2 of the poor prognostic indicators may be eligible.

          -  Patients with plasma cell leukemia

          -  Non-secretory multiple myeloma patients are eligible

          -  Patients between the ages of 18 and 75 years old

          -  Female Patients of child bearing age (up to age 50) who are not pregnant and agree to
             use two adequate birth control methods during the study and at least six months after
             treatment unless patient has undergone hysterectomy or has been in menopause for 2
             years.

          -  Patients with Southwest Oncology Group (SWOG) performance status of 3 or better

          -  Patients who have received prior lower dose Dexamethasone Therapy (ie. 4 mg QID) as
             adjunct to radiation therapy for cord compression may be eligible

          -  All patients must have a MUGA scan indicating a left ventricular ejection fraction
             (LVEF) of greater than or equal to 50% within 42 days prior to registration

          -  Must be able to understand English.

          -  Must be willing and eligible to sign up for the STEPS program

        Exclusion Criteria:

          -  Nursing mothers or women who are pregnant

          -  Patients with a history of hypersensitivity reaction to doxorubicin or agents in
             Doxil®

          -  Patients with previous malignancies at other sites except surgically treated
             nonmelanomatous skin cancers, prostate cancer or superficial cervical cancers, or
             other cancer from which the patient had been disease free for 5 or more years.

          -  History of mediastinal radiation for any reason

          -  History of receiving prior anthracyclines

          -  Patients with uncontrolled medical problems such as diabetes mellitus, cardiac,
             pulmonary, hepatic, and renal diseases unless renal insufficiency is felt to be
             secondary to multiple myeloma

          -  Myocardial infarction within 6 months of enrollment in the study.

          -  Major surgery within 4 weeks of enrollment.

          -  Patients previously treated or receiving other treatment for multiple myeloma other
             than lower doses dexamethasone as adjunct to radiotherapy

          -  Pre-existing peripheral neuropathy

          -  Patients with previously diagnosed malabsorption syndromes or anatomical abnormalities
             of the gastrointestinal tract that result in malabsorption syndromes.

          -  Patients with a history of cardiac disease, defined as New York Heart Association
             Class II or greater, or clinical evidence of congestive heart failure.

          -  Patients with psychiatric or central nervous systems disorders interfering with
             compliance of orally administered medication.

          -  Patients currently receiving anticoagulant therapy for venous thromboembolic episode
             or other hypercoagulable states.

          -  Patients who are unable to understand the English language.