Skip to main content
OpenTrials
Completed

NCT Number: NCT01122875

A Study of the Safety and Pharmacokinetics 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MFGR1877S

Drug

Intravenous repeating dose

Primary outcomes

  1. Incidence and nature of dose-limiting toxicities (DLTs)

    Time frame: Throughout study or until early study discontinuation

Secondary outcomes

  1. Incidence, nature, and severity of adverse events

    Time frame: Throughout study or until early study discontinuation

  2. Clinical activity of MFGR1877S (objective response, duration of response, and progression-free survival)

    Time frame: Throughout study or until early study discontinuation

  3. Pharmacokinetic parameters of MFGR1877S (total exposure, maximum and minimum serum concentrations, clearance, volume of distribution)

    Time frame: Throughout study or until early study discontinuation

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 13, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.