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

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: MFGR1877S

• Registration Number: NCT01122875
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-13
• Study Start: 2010-11
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	MFGR1877S	-

Primary Outcome Measures

Name	Time	Method
Incidence and nature of dose-limiting toxicities (DLTs)	Throughout study or until early study discontinuation

Secondary Outcome Measures

Name	Time	Method
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
Incidence, nature, and severity of adverse events	Throughout study or until early study discontinuation