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

NCT ID: NCT02811978

Last Updated: 2019-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-27
• Study Completion Date: 2018-11-10

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 : Intravenous Bortezomib plus Dexamethasone

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).

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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).

Group 2 : Subcutaneous Bortezomib plus Dexamethasone

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).

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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).

Interventions

Bortezomib

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

Intervention Type: DRUG

Dexamethasone

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).

Intervention Type: DRUG

Other Intervention Names

Velcade; JNJ-26866138-AAA

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Beijing, , China

Chengdu, , China

Chongqing, , China

Fuzhou, , China

Guangzhou, , China

Nanjing, , China

Shanghai, , China

Suzhou, , China

Tianjin, , China

Wuhan, , China

Countries

China

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=CR108175&attachmentIdentifier=77e89ae3-7f6b-4eb6-8499-925c2be8f4d6&fileName=CR108175_CSR_Synopsis.pdf&versionIdentifier=

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

Other Identifiers

26866138MMY3037

Identifier Type: OTHER

Identifier Source: secondary_id

CR108175

Identifier Type: -

Identifier Source: org_study_id