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

NCT02811978 | Completed Phase 3

• 2 other identifiers: CR10817526866138MMY3037
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (12)

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

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

• Overall Response Rate (ORR) after 8 cycles

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

• Progression-Free Survival (PFS)

  Maximum up to 4 years 7 months

• One-year survival rate

  1 year after last patient randomization

• Time to response

  Maximum up to 4 years 7 months

Study Arms (2)

Group 1 : Intravenous Bortezomib plus Dexamethasone

EXPERIMENTAL

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).

Drug: Bortezomib; Drug: Dexamethasone

Group 2 : Subcutaneous Bortezomib plus Dexamethasone

EXPERIMENTAL

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).

Drug: Bortezomib; Drug: Dexamethasone

Interventions

Bortezomib DRUG

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

Also known as: Velcade, JNJ-26866138-AAA

Group 1 : Intravenous Bortezomib plus Dexamethasone; Group 2 : Subcutaneous Bortezomib plus Dexamethasone

Dexamethasone 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 1 : Intravenous Bortezomib plus Dexamethasone; Group 2 : Subcutaneous Bortezomib plus Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (10)

Unknown Facility

Beijing, China

Location

Unknown Facility

Chengdu, China

Location

Unknown Facility

Chongqing, China

Location

Unknown Facility

Fuzhou, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Suzhou, China

Location

Unknown Facility

Tianjin, China

Location

Unknown Facility

Wuhan, China

Location

Related Links

• 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

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 23, 2016
• Study Start: September 27, 2016
• Primary Completion: May 7, 2018
• Study Completion: November 10, 2018
• Last Updated: November 8, 2019

Record last verified: 2019-10

Locations

CN (10)