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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122875
• Other study ID #: MFG4809g
• Secondary ID: GO01331
• Status: Completed
• Phase: Phase 1
• First received: May 11, 2010
• Last updated: November 1, 2016
• Start date: November 2010
• Est. completion date: May 2012

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• MFGR1877S
Intravenous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of dose-limiting toxicities (DLTs)		Throughout study or until early study discontinuation	No
Secondary	Incidence, nature, and severity of adverse events		Throughout study or until early study discontinuation	No
Secondary	Clinical activity of MFGR1877S (objective response, duration of response, and progression-free survival)		Throughout study or until early study discontinuation	No
Secondary	Pharmacokinetic parameters of MFGR1877S (total exposure, maximum and minimum serum concentrations, clearance, volume of distribution)		Throughout study or until early study discontinuation	No