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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Bortezomib; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02811978

CR108175

26866138MMY3037 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Group 1 : Intravenous Bortezomib plus Dexamethasone

Experimental group

Description:

Participants will receive a 1.3 milligram per square meter per dose (mg/m\^2) bortezomib intravenously on Days 1, 4, 8, and 11 of a 3 week cycle. Participants will receive Dexamethasone at a dose of 20 mg oral (PO) on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle).

Treatment:

Drug: Dexamethasone

Drug: Bortezomib

Group 2 : Subcutaneous Bortezomib plus Dexamethasone

Experimental group

Description:

Participants will receive a 1.3 milligram per square meter per dose (mg/m\^2) bortezomib subcutaneously on Days 1, 4, 8, and 11 of a 3 week cycle. Participants will receive Dexamethasone at a dose of 20 mg oral (PO) on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle).

Treatment:

Drug: Dexamethasone

Drug: Bortezomib