A Study of the Safety and Pharmacokinetics of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma
This study has been completed.
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01122875
First received: May 11, 2010
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
This is a multicenter, open-label, dose-escalation study of MFGR1877S in patients with relapsed or refractory t(4;14)-positive multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: MFGR1877S |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Throughout study or until early study discontinuation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence, nature, and severity of adverse events [ Time Frame: Throughout study or until early study discontinuation ] [ Designated as safety issue: No ]
- Clinical activity of MFGR1877S (objective response, duration of response, and progression-free survival) [ Time Frame: Throughout study or until early study discontinuation ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters of MFGR1877S (total exposure, maximum and minimum serum concentrations, clearance, volume of distribution) [ Time Frame: Throughout study or until early study discontinuation ] [ Designated as safety issue: No ]
| Enrollment: | 14 |
| Study Start Date: | November 2010 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: MFGR1877S
Intravenous repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122875
Locations
| United States, Arizona | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60611 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| New York, New York, United States, 10065 | |
| United States, Texas | |
| Dallas, Texas, United States, 75246 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Washington | |
| Seattle, Washington, United States, 98109 | |
| Canada, Ontario | |
| Toronto, Ontario, Canada, M5G 2M9 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01122875 History of Changes |
| Other Study ID Numbers: | MFG4809g, GO01331 |
| Study First Received: | May 11, 2010 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013