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A Phase I/II Study of Immunotherapy With hLL1 Administered Twice Weekly for 4 Consecutive Weeks in Patients With Multiple Myeloma

Phase 1/Phase 2
18 Years
Not Enrolling
Multiple Myeloma, Myeloma, Plasma-Cell, PLASMACYTOMA

Thank you

Trial Information

A Phase I/II Study of Immunotherapy With hLL1 Administered Twice Weekly for 4 Consecutive Weeks in Patients With Multiple Myeloma

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.

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

- 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

- 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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety and tolerability of hLL1 administered twice weekly for 4 consecutive weeks

Outcome Time Frame:

first 12 weeks, then over 2 years

Safety Issue:


Principal Investigator

William Wegener, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Immunomedics, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Myeloma, Plasma-Cell
  • Plasmacytoma
  • multiple myeloma
  • Myeloma, Plasma-Cell
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



Roswell Park Cancer InstituteBuffalo, New York  14263
Hackensack University Medical CenterHackensack, New Jersey  07601
New York Presbyterian Hospital/Cornell Medical CenterNew York, New York  10021
Winship Cancer Institute, Emory UniversityAtlanta, Georgia  30322
Center for Cancer CareGoshen, Indiana  46526
Hospital University of PennsylvaniaPhiladelphia, Pennsylvania  19104