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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


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
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