Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2007-01-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Multiple Doses
Multiple Dose levels
milatuzumab
twice weekly dosing for 4 weeks, total of 8 doses
Interventions
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milatuzumab
twice weekly dosing for 4 weeks, total of 8 doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female, \>/=18 years old;
* Meets clinical trial criteria for a diagnosis of multiple myeloma (Appendix 1)
* Stage II or III at study entry by Durie-Salmon staging, with either renal function subclassification (A or B) allowed (Appendix 2).
* Secretory multiple myeloma one or more criteria for measurable disease (serum M protein \>1.0 gm/dl measured by serum protein electrophoresis, serum free light chain measurement \>200 mg/dl, urinary M protein excretion \>200 mg/24 hours);
* Refractory or relapsed to at least two prior standard systemic anti-myeloma treatment regimens;
* Adequate performance status (Karnofsky Scale \>/= 60%);
* Life expectancy at least 6 months;
* Adequate hematologic status within 2 weeks before study drug administration:
* Hemoglobin \>8.0 g/dL and platelets \> 50,000/mm3 (both without transfusion or other hematologic support within 7 days of laboratory testing)
* White blood count (WBC) \> 2,000/mm3and absolute neutrophil count (ANC) \>1,000/mm3 (both without the use of colony stimulating factors within 7 days of laboratory testing)
* Adequate renal function: serum creatinine \< 1.5 x the upper limit of normal (ULN);
* Adequate hepatic function AST or ALT \< 2.5 x the ULN; Total bilirubin \< 1.5 x the ULN
Exclusion Criteria
* Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last hLL1 infusion;
* Prior chemotherapy, immunotherapy, radiotherapy, plasmapheresis, kyphoplasty, or major surgery within 4 weeks; prior stem cell transplant within 12 weeks; prior treatment with rituximab within 6 months. Must have recovered from all toxicity from prior treatments;
* Prior therapy with other murine, chimeric, human or humanized monoclonal antibodies, unless HAHA tested and negative;
* Prior treatment with any investigational agents within 3 months, unless completed follow-up, off study, and agreed by Sponsor;
* Prior malignancy within 5 years, excluding multiple myeloma, non-melanoma skins cancers and cervical carcinoma in situ;
* Known to be HIV positive, or hepatitis B or C positive;
* Known autoimmune disease or presence of autoimmune phenomena;
* Systemic infection or requiring anti-infectives within 7 days before first dose of study drug;
* Substance abuse or other concurrent medical conditions that, in the investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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William Wegener, MD, PhD
Role: STUDY_CHAIR
Gilead Sciences
Locations
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Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Center for Cancer Care
Goshen, Indiana, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York Presbyterian Hospital/Cornell Medical Center
New York, New York, United States
Hospital University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Sapra P, et al. In vitro and in vivo targeting and therapy of an antibody-drug conjugate (IMMU-110) in B-cell malignancies. (Abstract #3287) Blood 2004; 104/11:898a.
Stein R, et al. Therapeutic activity of a new antibody-drug immunoconjugate, IMMU-110, in preclinical studies targeted against multiple myeloma. (Abstract #6535) Proceedings of ASCO 2004; 23:564.
Griffiths GL, et al. Promising therapeutic activity of a new drug immunoconjugate, IMMU-110, in a human Burkitt lymphoma model. (Abstract #2381) Blood 2003; 102/11:645a
Chang CH, Sapra P, Vanama SS, Hansen HJ, Horak ID, Goldenberg DM. Effective therapy of human lymphoma xenografts with a novel recombinant ribonuclease/anti-CD74 humanized IgG4 antibody immunotoxin. Blood. 2005 Dec 15;106(13):4308-14. doi: 10.1182/blood-2005-03-1033. Epub 2005 Aug 18.
Stein R, Qu Z, Cardillo TM, Chen S, Rosario A, Horak ID, Hansen HJ, Goldenberg DM. Antiproliferative activity of a humanized anti-CD74 monoclonal antibody, hLL1, on B-cell malignancies. Blood. 2004 Dec 1;104(12):3705-11. doi: 10.1182/blood-2004-03-0890. Epub 2004 Aug 5.
Vanama SS, et al. Construction and characterization of a novel ribonuclease immunotoxin consisting of two Ranpirnase (Rap) molecules fused to an internalizing anti-CD74 humanized IgG4 antibody. (Abstract #3289) Blood 2004; 104/11:899a.
Burton JD, Ely S, Reddy PK, Stein R, Gold DV, Cardillo TM, Goldenberg DM. CD74 is expressed by multiple myeloma and is a promising target for therapy. Clin Cancer Res. 2004 Oct 1;10(19):6606-11. doi: 10.1158/1078-0432.CCR-04-0182.
Griffiths GL, Mattes MJ, Stein R, Govindan SV, Horak ID, Hansen HJ, Goldenberg DM. Cure of SCID mice bearing human B-lymphoma xenografts by an anti-CD74 antibody-anthracycline drug conjugate. Clin Cancer Res. 2003 Dec 15;9(17):6567-71.
Ong GL, Goldenberg DM, Hansen HJ, Mattes MJ. Cell surface expression and metabolism of major histocompatibility complex class II invariant chain (CD74) by diverse cell lines. Immunology. 1999 Oct;98(2):296-302. doi: 10.1046/j.1365-2567.1999.00868.x.
Kaufman JL, Niesvizky R, Stadtmauer EA, Chanan-Khan A, Siegel D, Horne H, Wegener WA, Goldenberg DM. Phase I, multicentre, dose-escalation trial of monotherapy with milatuzumab (humanized anti-CD74 monoclonal antibody) in relapsed or refractory multiple myeloma. Br J Haematol. 2013 Nov;163(4):478-86. doi: 10.1111/bjh.12565. Epub 2013 Sep 25.
Related Links
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Related Info
Other Identifiers
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PROTOCOL: IMMU-115-01
Identifier Type: -
Identifier Source: org_study_id
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