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

Last updated: November 7, 2019
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Leukemia

Cancer

Lymphoproliferative Disorders

Treatment

N/A

Clinical Study ID

NCT02811978
CR108175
26866138MMY3037
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Have received at least 1 and no more than 3 prior lines of therapy for multiplemyeloma

  • 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 lessthan or equal (<=)Grade 1 prior to drug administration

  • A woman of childbearing potential must have a negative highly sensitive serum (humanchorionic gonadotropin [hCG]) or urine pregnancy tests at screening within 14 daysprior to Cycle 1 Day 1

  • Have documented evidence of progressive disease/disease progression based oninvestigator's determination of response by the International Myeloma Working Group (IMWG) criteria on or after their last regimen

Exclusion

Exclusion Criteria:

  • Received antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of thetreatment, whichever is longer, before the date of randomization. The only exceptionis emergency use of a short course of corticosteroids (equivalent of dexamethasone 40milligram per day (mg/day) for a maximum of 4 days) before treatment.

  • Received autologous stem cell transplant (ASCT) within 12 weeks before the date ofrandomization, or the participant has previously received an allogenic stem celltransplant (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 burdenprior to transplant

  • Is known to be infected with human immunodeficiency virus (HIV) or active infectionwith hepatitis B or hepatitis C

  • Had myocardial infarction within 6 months prior to enrollment or has New York HeartAssociation (NYHA) Class III or IV heart failure, uncontrolled angina, severeuncontrolled ventricular arrhythmias, or electrocardiographic evidence of acuteischemia or clinically significant conduction system abnormalities

Study Design

Total Participants: 81
Study Start date:
September 27, 2016
Estimated Completion Date:
November 10, 2018

Connect with a study center

  • Beijing,
    China

    Site Not Available

  • Chengdu,
    China

    Site Not Available

  • Chongqing,
    China

    Site Not Available

  • Fuzhou,
    China

    Site Not Available

  • Guangzhou,
    China

    Site Not Available

  • First Affiliated Hospital, Medical School of Zhejiang University

    Hangzhou, 310020
    China

    Site Not Available

  • Nanjing,
    China

    Site Not Available

  • The Affiliated Hospital of Medical College Qingdao University

    Qingdao, 266003
    China

    Site Not Available

  • Shanghai,
    China

    Site Not Available

  • Suzhou,
    China

    Site Not Available

  • The Second Hospital Of Shanxi Medical University

    Taiyuan, 30001
    China

    Site Not Available

  • Tianjin,
    China

    Site Not Available

  • Wuhan,
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, 221003
    China

    Site Not Available

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