NCT01122875

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

May 11, 2010

Last Update Submit

November 1, 2016

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Incidence and nature of dose-limiting toxicities (DLTs)

    Throughout study or until early study discontinuation

Secondary Outcomes (3)

  • Incidence, nature, and severity of adverse events

    Throughout study or until early study discontinuation

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

    Throughout study or until early study discontinuation

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

    Throughout study or until early study discontinuation

Study Arms (1)

A

EXPERIMENTAL
Drug: MFGR1877S

Interventions

MFGR1877SDRUG

Intravenous repeating dose

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Scottsdale, Arizona, 85259, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Boston, Massachusetts, 02111, United States

Location

Unknown Facility

Ann Arbor, Michigan, 48109, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

Hackensack, New Jersey, 07601, United States

Location

Unknown Facility

New York, New York, 10065, United States

Location

Unknown Facility

Dallas, Texas, 75246, United States

Location

Unknown Facility

Salt Lake City, Utah, 84132-0001, United States

Location

Unknown Facility

Seattle, Washington, 98109, United States

Location

Unknown Facility

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

vofatamab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Clinical Trials

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2010

First Posted

May 13, 2010

Study Start

November 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

CA(1)US(11)