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

Genentech

Status and phase

Completed

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: MFGR1877S

Study type

Interventional

Funder types

Industry

Identifiers

GO01331 (Other Identifier)

MFG4809g

Details and patient eligibility

About

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

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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