Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: bortezomib; dexamethasone; doxorubicin HCl liposome
Intervention description: Patients will be treated with bortezomib at 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days (cycle).; Dexamethasone tablets will be given at 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days (cycle).; Patients will receive intravenous doxorubicin HCl liposome injection given at 30 mg/m^2 on Day 4 every 28 days (cycle).
Intervention MeSH terms: Dexamethasone; Doxorubicin; Liposomal doxorubicin; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed Multiple Myeloma; Refractory Multiple Myeloma

Summary:

      The current study is being conducted to evaluate the possibility that a different schedule of
      bortezomib, doxorubicin HCl liposome, and dexamethasone might decrease the incidence of
      peripheral neuropathy yet maintain similar efficacy and allow maintenance of bortezomib
      dosing for a longer period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is at least 18 years of age.

          -  Patient has confirmed diagnosis of relapsed/refractory multiple myeloma with
             measurable disease by serum or urine. Measurable disease defined as monoclonal protein
             of ≥ 1g/dl on serum protein electrophoresis (SPEP) or > 200 mg urine M protein/ 24
             hours

          -  Patient has received at least 1 prior treatment regimen. (Prior treatment with
             bortezomib is allowed.)

          -  Patient has ECOG ≤ 2

          -  Patient provides voluntary written informed consent before performance of any
             study-relates procedure not part of normal medical care, with the understanding that
             consent may be withdrawn by the subject at any time without prejudice to future
             medical care.

          -  Patients who have received prior high dose chemotherapy with stem cell support are
             eligible for this study.

          -  Female subject is either post-menopausal or surgically sterilized or willing to use an
             acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine
             device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
             duration of the study.

          -  Male subject agrees to use an acceptable method for contraception for the duration of
             the study.

        Exclusion Criteria:

          -  Patient has a platelet count of < 50, 000 cells/mm³, within 14 days before enrollment.

          -  Patient has an absolute neutrophil count (ANC) ≤ 750/mm³ within 14 days before
             enrollment.

          -  Patient has a calculated or measured creatinine clearance of < 20 mL/min within 14
             days before enrollment and/or serum creatinine ≥ 2.5 mg/dl.

          -  Patient has hemoglobin < 7.5 g/dl.

          -  Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.

          -  Myocardial infarction within 6 months prior to enrollment or has (NYHA) Class III or
             IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or
             electrocardiographic evidence of acute ischemia or active conduction system
             abnormalities. Prior to study entry, any electrocardiogram (ECG) abnormality at
             screening has to be documented by the investigator as not medically relevant.

          -  Patient has received a total cumulative dosage of anthracyclines exceeding 550 mg/m2.

          -  Patient has hypersensitivity to boron or mannitol.

          -  Patient has history of hypersensitivity reactions to a conventional formulation of
             doxorubicin HCl or the components of DOXIL.

          -  Patient has clinically significant coexisting illness unrelated to myeloma.

          -  Patient has uncontrolled diabetes.

          -  Patient has plasma cell leukemia.

          -  Patient has serum bilirubin > 1.5 x upper normal limit, alanine aminotransaminase
             (ALT), aspartate aminotransferase (AST) > 2.5 x upper normal limit (ULN), or alkaline
             phosphatase > 2.5 x ULN.

          -  Female subject is pregnant or breast-feeding. Confirmation that the subject is not
             pregnant must be established by a negative serum beta-human chorionic gonadotropin
             (B-hCG)pregnancy test result obtained during screening. Pregnancy testing is not
             required for post-menopausal or surgically sterilized women.

          -  Patient has received other investigational drugs within 14 days before enrollment.

          -  Patient has serious medical or psychiatric illness likely to interfere with
             participation in this clinical study.