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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01122875
First received: May 11, 2010
Last updated: January 15, 2013
Last verified: January 2013
History of Changes

May 11, 2010
January 15, 2013
November 2010
September 2012   (final data collection date for primary outcome measure)
Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Throughout study or until early study discontinuation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01122875 on ClinicalTrials.gov Archive Site
  • Incidence, nature, and severity of adverse events [ Time Frame: Throughout study or until early study discontinuation ] [ Designated as safety issue: No ]
  • Clinical activity of MFGR1877S (objective response, duration of response, and progression-free survival) [ Time Frame: Throughout study or until early study discontinuation ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of MFGR1877S (total exposure, maximum and minimum serum concentrations, clearance, volume of distribution) [ Time Frame: Throughout study or until early study discontinuation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Safety and Pharmacokinetics of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: MFGR1877S
Intravenous repeating dose
Experimental: A
Intervention: Drug: MFGR1877S
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
October 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01122875
MFG4809g, GO01331
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP