Back to resultsA Study of the Safety and Pharmacokinetics of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MFGR1877S
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Incidence and nature of dose-limiting toxicities (DLTs)
Secondary Outcome Measures
Incidence, nature, and severity of adverse events
Clinical activity of MFGR1877S (objective response, duration of response, and progression-free survival)
Pharmacokinetic parameters of MFGR1877S (total exposure, maximum and minimum serum concentrations, clearance, volume of distribution)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01122875
Brief Title
A Study of the Safety and Pharmacokinetics of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MFGR1877S
Intervention Description
Intravenous repeating dose
Primary Outcome Measure Information:
Title
Incidence and nature of dose-limiting toxicities (DLTs)
Time Frame
Throughout study or until early study discontinuation
Secondary Outcome Measure Information:
Title
Incidence, nature, and severity of adverse events
Time Frame
Throughout study or until early study discontinuation
Title
Clinical activity of MFGR1877S (objective response, duration of response, and progression-free survival)
Time Frame
Throughout study or until early study discontinuation
Title
Pharmacokinetic parameters of MFGR1877S (total exposure, maximum and minimum serum concentrations, clearance, volume of distribution)
Time Frame
Throughout study or until early study discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-0001
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety and Pharmacokinetics of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma
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