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

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

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: MFGR1877S


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: MFGR1877S<br>* Intravenous repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and nature of dose-limiting toxicities (DLTs) |  | Throughout study or until early study discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |