Study of Subcutaneous and Intravenous Velcade in Combination With Dexamethasone in Chinese Subjects With Relapsed and Refractory Multiple Myeloma
Study of Subcutaneous and Intravenous Velcade in Combination With Dexamethasone in Chinese Subjects With Relapsed and Refractory Multiple Myeloma
The purpose of this phase 3 study is to determine if subcutaneous velcade is non-inferior to
 intravenous velcade when administered in combination with low-dose dexamethasone in chinese
 refractory or relapsed multiple myeloma (r/rMM) patients. The study will assess the overall
 response rate after 4 cycles of velcade and dexamethasone administration.
Inclusion Criteria:

 -  Have received at least 1 and no more than 3 prior lines of therapy for multiple
 myeloma

 -  Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or
 2

 -  The toxicities resulting from previous therapy must be resolved or stabilized to less
 than or equal (<=)Grade 1 prior to drug administration

 -  A woman of childbearing potential must have a negative highly sensitive serum (human
 chorionic gonadotropin [hCG]) or urine pregnancy tests at screening within 14 days
 prior to Cycle 1 Day 1

 -  Have documented evidence of progressive disease/disease progression based on
 investigator's determination of response by the International Myeloma Working Group
 (IMWG) criteria on or after their last regimen

 Exclusion Criteria:

 -  Received antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the
 treatment, whichever is longer, before the date of randomization. The only exception
 is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40
 milligram per day (mg/day) for a maximum of 4 days) before treatment.

 -  Received autologous stem cell transplant (ASCT) within 12 weeks before the date of
 randomization, or the participant has previously received an allogenic stem cell
 transplant (regardless of timing)

 -  Plans to undergo a stem cell transplant prior to progression of disease on this study,
 that is, these participants should not be enrolled in order to reduce disease burden
 prior to transplant

 -  Is known to be infected with human immunodeficiency virus (HIV) or active infection
 with hepatitis B or hepatitis C

 -  Had myocardial infarction within 6 months prior to enrollment or has New York Heart
 Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
 uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
 ischemia or clinically significant conduction system abnormalities