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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01122875
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: MFGR1877S Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: A Drug: MFGR1877S
Intravenous repeating dose




Primary Outcome Measures :
  1. Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Throughout study or until early study discontinuation ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122875


Locations
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United States, Arizona
Scottsdale, Arizona, United States, 85259
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Massachusetts
Boston, Massachusetts, United States, 02111
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Detroit, Michigan, United States, 48201
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, New York
New York, New York, United States, 10065
United States, Texas
Dallas, Texas, United States, 75246
United States, Utah
Salt Lake City, Utah, United States, 84132-0001
United States, Washington
Seattle, Washington, United States, 98109
Canada, Ontario
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01122875     History of Changes
Other Study ID Numbers: MFG4809g
GO01331 ( Other Identifier: Hoffmann-La Roche )
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases