A Study of the Safety and Pharmacokinetics of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma
Status: | Completed |
---|---|
Conditions: | Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/3/2016 |
Start Date: | November 2010 |
End Date: | May 2012 |
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.
relapsed or refractory t(4;14)-positive multiple myeloma.
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
We found this trial at
12
sites
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