Study of Subcutaneous and Intravenous Velcade in Combination With Dexamethasone in Chinese Subjects With Relapsed and Refractory Multiple Myeloma

Phase 3CompletedNCT02811978

Janssen Research & Development, LLC81 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

BortezomibDRUG

Participants will receive 1.3 mg/m\^2 bortezomib on Days 1, 4, 8, and 11 of a 3 week cycle.

DexamethasoneDRUG

Participants will receive Dexamethasone at a dose of 20 mg PO on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Unnamed facility

Beijing, China

Unnamed facility

Chengdu, China

Unnamed facility

Chongqing, China

Unnamed facility

Fuzhou, China

Outcomes

Primary Outcomes

Overall Response Rate After 4 Cycles of Velcade Treatment

ORR defined as the proportion of participants who achieve either complete response \[CR\], very good partial response \[VGPR\], or partial response \[PR\], according to the International Myeloma Working Group (IMWG) criteria. Participants with CR, VGPR, or PR that is unconfirmed in Cycle 4 but confirmed in the next response assessment will be included as CR, VGPR or PR, respectively.

Time frame: 12 weeks (after 4 cycles; each cycle is of 3 weeks)

Secondary Outcomes

Complete Response (CR) and Very Good Partial Response (VGPR) after 4 cycles

CR and VGPR defined as the proportion of participants who achieve either complete response \[CR\] or very good partial response \[VGPR\], according to the IMWG criteria, after 4 cycles of Velcade treatment. Participants with CR or VGPR that is unconfirmed in Cycle 4 but further confirmed in the next response assessment will be included.

Time frame: 12 weeks (after 4 cycles; each cycle is of 3 weeks)

Overall Response Rate (ORR) after 8 cycles

ORR is defined as the proportion of participants who achieve either CR, VGPR, or PR according to the IMWG criteria, after 8 cycles of Vd treatment. Participants with CR, VGPR or PR that is unconfirmed in Cycle 8 but further confirmed in the next response assessment will be included.

Time frame: 24 weeks (after 8 cycle; each cycle is of 3 weeks)

Progression-Free Survival (PFS)

PFS is defined as the time from the date of randomization to the date of first documented progressive disease/disease progression (PD), or death due to any cause, whichever occurs earlier. Participants who have not progressed and are alive on the cut-off date for analysis will be censored at the date of the last clinical assessment of response.

Time frame: Maximum up to 4 years 7 months

One-year survival rate

Data from ClinicalTrials.gov

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