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A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Refractory or Recurrent Multiple Myeloma

Phase 1
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Refractory or Recurrent Multiple Myeloma

This is an open-label, multi-dose, single-arm, phase I, dose-escalation study to define the
toxicity profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of
SGN-40 in patients with refractory or recurrent multiple myeloma.

A minimum of three patients will be entered into each dose-level cohort. All patients will
receive a dose-loading schedule during the first two weeks. The maximum weekly dose will be

Inclusion Criteria:

1. Patients must have refractory or recurrent secretory multiple myeloma (MM).

2. Patients must have failed at least two different prior systemic therapies for MM.

3. Patients may have received a maximum of five cytotoxic regimens.

4. Patients who have received any of the following must complete within the specified
time frame below:

- Autologous stem cell transplant - 12 weeks prior to first dose

- Nitrogen Mustard agents, Melphalan, BCNU, IVIG, or monoclonal antibody therapy -
6 weeks prior to first dose

- Chemotherapy, Radiation, or other therapies for MM - 4 weeks prior to first dose

5. Patients who have not undergone autologous stem cell transplantation must be either
ineligible for stem cell transplantation or, if eligible, must have refused treatment
by autologous stem cell transplantation.

6. Patients must have an ECOG performance status of ≤ 2 and a life expectancy > three

7. Patients must be available for periodic blood sampling, study-related assessments,
and management of toxicity at the treating institution for the entire duration of the

8. Patients must be at least 18 years of age.

9. Females of childbearing potential must have a negative β-HCG pregnancy test result
within three days of enrollment. All patients must plan to use an effective
contraceptive method during the course of the study.

10. Patients must meet baseline lab data requirements.

11. Patients must give written informed consent.

Exclusion Criteria:

1. Patients with non-secretory MM or solitary plasmacytoma or plasma cell leukemia.

2. Patients with a history of allogeneic transplantation.

3. Patients receiving plasmapheresis within four weeks prior to enrollment.

4. Patients undergoing major surgery within four weeks prior to enrollment.

5. Patients with a known hypersensitivity to recombinant proteins or any excipient
contained in the drug formulation.

6. Patients with a history of other malignancies during the past five years with the
exception of adequately treated basal or squamous cell skin cancer or cervical
carcinoma in situ.

7. Patients with any active viral, bacterial, or systemic fungal infection within four
weeks of enrollment.

8. Patients with a history of significant chronic or recurrent infections requiring

9. Patients with a history of active thrombosis within three months of enrollment.

10. Patients with a history of pulmonary embolism.

11. Patients with a history of migraines or severe headaches requiring medical therapy
within 12 months of enrollment.

12. Patients who are pregnant or breastfeeding.

13. Patients with uncontrolled hypercalcemia.

14. Patients with any serious underlying medical condition that would impair their
ability to receive or tolerate the planned treatment.

15. Patients with dementia or altered mental status that would preclude understanding and
rendering of informed consent.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events and lab abnormalities.

Safety Issue:


Principal Investigator

Nancy Whiting, PharmD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

November 2007

Related Keywords:

  • Multiple Myeloma
  • Antigens, CD40
  • Antibody, Monoclonal
  • Blood Coagulation Disorders
  • Hematologic Diseases
  • Hemorrhagic Disorders
  • Hemostatic Disorders
  • Immunoproliferative Disorders
  • Lymphoproliferative Disorders
  • Paraproteinemias
  • Vascular Diseases
  • Antibody-Dependent Cell Cytotoxicity
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Rocky Mountain Cancer Center Denver, Colorado  80218
Dana Farber Cancer Institute Boston, Massachusetts  02115
The Cleveland Clinic Cleveland, Ohio  44195
James R. Berenson M.D., Inc. West Hollywood, California  90069
Cornell University New York, New York  10021