Multiple Myeloma
Conditions
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.
Interventions
DRUGMFGR1877S
Intravenous repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and nature of dose-limiting toxicities (DLTs) | Throughout study or until early study discontinuation |
Secondary
| Measure | 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 |
Countries
Canada, United States
Outcome results
None listed