Phase I/II Study of hLL1 in Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421525
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : October 4, 2012
Information provided by (Responsible Party):
Immunomedics, Inc.

Brief Summary:
This is a Phase I/II, open-label, multi-center study conducted in patients with recurrent or refractory multiple myeloma who have failed at least two prior standard systemic treatments.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Myeloma, Plasma-Cell PLASMACYTOMA Biological: milatuzumab Phase 1 Phase 2

Detailed Description:
All patients receive hLL1 administered intravenously twice weekly for 4 consecutive weeks. Cohorts of 3-6 patients will receive escalating doses of hLL1 in order to determine the maximum tolerated dose (MTD) for this administration schedule. Up to approximately 30 additional patients will be entered at one or more dose levels at or below the MTD in order to determine the optimal dose for subsequent studies.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Immunotherapy With hLL1 Administered Twice Weekly for 4 Consecutive Weeks in Patients With Multiple Myeloma
Study Start Date : January 2007
Actual Primary Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Active Comparator: Multiple Doses
Multiple Dose levels
Biological: milatuzumab
twice weekly dosing for 4 weeks, total of 8 doses
Other Names:
  • CD74
  • humanized CD74
  • IMMU-115

Primary Outcome Measures :
  1. safety and tolerability of hLL1 administered twice weekly for 4 consecutive weeks [ Time Frame: first 12 weeks, then over 2 years ]

Secondary Outcome Measures :
  1. The secondary objectives are to obtain information on efficacy, pharmacodynamics, pharmacokinetics, and immunogenicity, and to determine the optimal dose for subsequent studies. [ Time Frame: first 12 weeks, then over 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Able to provide signed, informed consent;
  • 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:

  • Pregnant or lactating women.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00421525

United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Indiana
Center for Cancer Care
Goshen, Indiana, United States, 46526
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
New York Presbyterian Hospital/Cornell Medical Center
New York, New York, United States, 10021
United States, Pennsylvania
Hospital University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Immunomedics, Inc.
Study Chair: William Wegener, MD, PhD Immunomedics, Inc.

Additional Information:
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
Sapra P, et al. Preclinical safety and efficacy of two novel immunotoxins consisting of Ranpirnase (Rap) fused to an internalizing anti-CD74 humanized IgG4 antibody in human non-Hodgkin's lymphoma xenografts. (Abstract #346) Blood 2005; 106/11:105a
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.
Stein R, et al. Preclinical evaluation of a humanized anti-CD74 monoclonal antibody, hLL1, for treatment of B-cell malignancies. (Abstract #630) Blood 2003; 102/11: 181a

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Immunomedics, Inc. Identifier: NCT00421525     History of Changes
Other Study ID Numbers: PROTOCOL: IMMU-115-01
First Posted: January 12, 2007    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012

Keywords provided by Immunomedics, Inc.:
multiple myeloma
Myeloma, Plasma-Cell

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases