Clinical trial NCT02811978: Study of Subcutaneous and Intravenous Velcade in Combination With Dexamethasone in Chinese Subjects With Relapsed and Refractory Multiple Myeloma
Official title: A Phase 3, Randomized, Open-label Study of Subcutaneous and Intravenous VELCADE in Combination With Dexamethasone in Chinese Subjects With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-06-23
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate After 4 Cycles of Velcade Treatment
timeFrame: 12 weeks (after 4 cycles; each cycle is of 3 weeks)
Secondary outcomes:
measure: Complete Response (CR) and Very Good Partial Response (VGPR) after 4 cycles
timeFrame: 12 weeks (after 4 cycles; each cycle is of 3 weeks)
measure: Overall Response Rate (ORR) after 8 cycles
timeFrame: 24 weeks (after 8 cycle; each cycle is of 3 weeks)
measure: Progression-Free Survival (PFS)
timeFrame: Maximum up to 4 years 7 months
measure: One-year survival rate
timeFrame: 1 year after last patient randomization
measure: Time to response
timeFrame: Maximum up to 4 years 7 months
measure: Time to progression (TTP)
timeFrame: Maximum up to 4 years 7 months
measure: Duration of response (DOR)
timeFrame: Maximum up to 4 years 7 months
measure: Time to best response
timeFrame: Maximum up to 4 years 7 months
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Cycle 1 of Day 1, Day 11 to Day 14
measure: Area Under the Plasma ConcentrationTime Curve From Time 0 to Last Observed Quantifiable Concentration AUC [0-last]
timeFrame: Cycle 1 of Day 1, Day 11 to Day 14
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Cycle 1 of Day 1, Day 11 to Day 14
measure: Number of Participants with Treatment-Related Adverse Events and Serious Treatment-Related Adverse Events
timeFrame: Maximum up to 4 years 7 months
Other outcomes:
Locations:
city: Beijing
country: China
city: Chengdu
country: China
city: Chongqing
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Suzhou
country: China
city: Tianjin
country: China
city: Wuhan
country: China
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: