A Study of the Safety and Pharmacokinetics of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma

November 1, 2016 updated by: Genentech, Inc.

An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma

This is a multicenter, open-label, dose-escalation study of MFGR1877S in patients with relapsed or refractory t(4;14)-positive multiple myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Detroit, Michigan, United States, 48201
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • New York
      • New York, New York, United States, 10065
    • Texas
      • Dallas, Texas, United States, 75246
    • Utah
      • Salt Lake City, Utah, United States, 84132-0001
    • Washington
      • Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ECOG performance status of 0, 1, or 2
  • Life expectancy of at least 12 weeks
  • Histologic documentation of previously treated t(4;14)-positive multiple myeloma for which no effective standard therapy exists

Exclusion Criteria:

  • Prior use of any monoclonal antibody before study treatment
  • Treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 4 weeks of study treatment
  • Completion of autologous stem cell transplant within 6 months prior to study treatment
  • Prior allogeneic stem cell transplant
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
  • Evidence of significant, uncontrolled concomitant diseases, including significant cardiovascular disease or pulmonary disease
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at screening or any recent major episode of infection requiring treatment with IV antibiotics or hospitalization prior to study treatment
  • Recent major surgery (prior to study treatment), other than for diagnosis
  • Presence of positive test results for Hepatitis B or Hepatitis C
  • Known history of HIV seropositive status
  • Women who are pregnant or lactating
  • Childbearing potential without agreement to use effective form of contraception for the duration of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Drug: MFGR1877S
Intravenous repeating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and nature of dose-limiting toxicities (DLTs)
Time Frame: Throughout study or until early study discontinuation
Throughout study or until early study discontinuation

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence, nature, and severity of adverse events
Time Frame: Throughout study or until early study discontinuation
Throughout study or until early study discontinuation
Clinical activity of MFGR1877S (objective response, duration of response, and progression-free survival)
Time Frame: Throughout study or until early study discontinuation
Throughout study or until early study discontinuation
Pharmacokinetic parameters of MFGR1877S (total exposure, maximum and minimum serum concentrations, clearance, volume of distribution)
Time Frame: Throughout study or until early study discontinuation
Throughout study or until early study discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 11, 2010

First Posted (ESTIMATE)

May 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFG4809g
  • GO01331 (OTHER: Hoffmann-La Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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