Phase I/II Study of hLL1 in Multiple Myeloma

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00421525

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

4.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

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

Actual Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Multiple Doses Multiple Dose levels	Biological: milatuzumab twice weekly dosing for 4 weeks, total of 8 doses Other Names: CD74 humanized CD74 IMMU-115 hLL1

Arm

Intervention/Treatment

Other: Multiple Doses

Multiple Dose levels

Biological: milatuzumab

twice weekly dosing for 4 weeks, total of 8 doses

Other Names:

CD74

humanized CD74

IMMU-115

hLL1

Outcome Measures

Primary Outcome Measures

safety and tolerability of hLL1 administered twice weekly for 4 consecutive weeks [first 12 weeks, then over 2 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Winship Cancer Institute, Emory University	Atlanta	Georgia	United States	30322
2	Center for Cancer Care	Goshen	Indiana	United States	46526
3	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
4	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
5	New York Presbyterian Hospital/Cornell Medical Center	New York	New York	United States	10021
6	Hospital University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104