Inclusion Criteria

Inclusion Criteria

- Patient experienced PD, as defined by SWOG+ criteria during or after treatment with
high-dose dexamethasone in MPI Study M34101-039, but has not received alternate
anti-neoplastic therapy. Intolerance to high-dose dexamethasone therapy as
administered in MPI study M34101-039 does not qualify as PD.

- Patient is, in the investigator's opinion, willing and able to comply with the
protocol requirements.

- Patient has given voluntary written informed consent before performance of any
study-related procedure not part of normal medical care, with the understanding that
consent may be withdrawn by the patient at any time without prejudice to their future
medical care.

- Female patient is post-menopausal, surgically sterilized, or willing to use
acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) from
Screening through the End of Treatment visit.

- Male patient agrees to use an acceptable barrier method for contraception from
Screening through the End of Treatment visit.

- Patient meets the following pretreatment laboratory criteria at and within 14 days
before Baseline (Day 1 of Cycle 1, before study drug administration). (Note that the
End of Treatment assessments of MPI study M34101-039 may qualify as the Screening
assessments for MPI study M34101-040 if performed within 14 days of the Baseline
visit.):

- Platelet count ≥20 X 10E+9/L, with or without transfusion support.

- Hemoglobin ≥7.0 g/dL, with or without transfusion support.

- Absolute neutrophil count (ANC)≥0.5 x 10E+9/L, without growth factor support.

- Serum calcium <14 mg/dL (3.5 mmol/L).

- Aspartate transaminase (AST):≤2.5 x the upper limit of normal (ULN).

- Alanine transaminase (ALT):≤2.5 x the ULN.

- Total bilirubin:≤1.5 x the ULN.

- If calculated or measured creatinine clearance: ≥20 mL/minute, assessments are as
specified in the protocol. If calculated or measured creatinine clearance is <20
mL/minute.

Exclusion Criteria

- Patient participated in M34101-039 and did not have confirmed PD. Dexamethasone
intolerance does not qualify as PD.

- Patient had PD on the dexamethasone arm of the MPI Study M34101-039, and then
received alternate anti-neoplastic therapy.

- Patient has not recovered from dexamethasone-related toxicity experienced during MPI
Study M34101-039.

- Patient is known to be human immunodeficiency virus (HIV)-positive.(Patients assessed
by the investigator to be at risk for HIV infection should be tested in accordance
with local regulations.)

- Patient is known to be hepatitis B surface antigen-positive or has known active
hepatitis C infection.(Patients assessed by the investigator to be at risk for
hepatitis B or C infection should be tested in accordance with local regulations.)

- Female patient is pregnant or breast-feeding.

- Patient developed a new or experienced worsening of an existing illness during or
after completion of Study M34101-039 that, in the investigator's opinion, may put the
patient at risk of participation in this study.