NCT00079716

Brief Summary

The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Timeline
Completed

Started Mar 2004

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2004

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

3.4 years

First QC Date

March 11, 2004

Last Update Submit

December 17, 2014

Conditions

Multiple Myeloma

Keywords

Antigens, CD40Antibody, MonoclonalBlood Coagulation DisordersHematologic DiseasesHemorrhagic DisordersHemostatic DisordersImmunoproliferative DisordersLymphoproliferative DisordersParaproteinemiasVascular DiseasesAntibody-Dependent Cell Cytotoxicity

Outcome Measures

Primary Outcomes (1)

  • Adverse events and lab abnormalities.

Study Arms (1)

1

EXPERIMENTAL
Drug: SGN-40 (anti-huCD40 mAb)

Interventions

SGN-40 (anti-huCD40 mAb)DRUG

0.5-8 mg/kg IV (in the vein) on Day 1; 0-8 mg/kg on Day 4; 0.5-16 mg/kg on Days 8 and 15; 0-16 mg/kg on Day 29.

Also known as: dacetuzumab
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have refractory or recurrent secretory multiple myeloma (MM).
  • Patients must have failed at least two different prior systemic therapies for MM.
  • Patients may have received a maximum of five cytotoxic regimens.
  • 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
  • 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.
  • Patients must have an ECOG performance status of ≤ 2 and a life expectancy \> three months.
  • 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 study.
  • Patients must be at least 18 years of age.
  • 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.
  • Patients must meet baseline lab data requirements.
  • Patients must give written informed consent.

You may not qualify if:

  • Patients with non-secretory MM or solitary plasmacytoma or plasma cell leukemia.
  • Patients with a history of allogeneic transplantation.
  • Patients receiving plasmapheresis within four weeks prior to enrollment.
  • Patients undergoing major surgery within four weeks prior to enrollment.
  • Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
  • 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.
  • Patients with any active viral, bacterial, or systemic fungal infection within four weeks of enrollment.
  • Patients with a history of significant chronic or recurrent infections requiring treatment.
  • Patients with a history of active thrombosis within three months of enrollment.
  • Patients with a history of pulmonary embolism.
  • Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment.
  • Patients who are pregnant or breastfeeding.
  • Patients with uncontrolled hypercalcemia.
  • Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
  • Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

James R. Berenson M.D., Inc.

West Hollywood, California, 90069, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Cornell University

New York, New York, 10021, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

  • Hayashi T, Treon SP, Hideshima T, Tai YT, Akiyama M, Richardson P, Chauhan D, Grewal IS, Anderson KC. Recombinant humanized anti-CD40 monoclonal antibody triggers autologous antibody-dependent cell-mediated cytotoxicity against multiple myeloma cells. Br J Haematol. 2003 May;121(4):592-6. doi: 10.1046/j.1365-2141.2003.04322.x.

    PMID: 12752100RESULT

  • Hussein M, Berenson JR, Niesvizky R, Munshi N, Matous J, Sobecks R, Harrop K, Drachman JG, Whiting N. A phase I multidose study of dacetuzumab (SGN-40; humanized anti-CD40 monoclonal antibody) in patients with multiple myeloma. Haematologica. 2010 May;95(5):845-8. doi: 10.3324/haematol.2009.008003. Epub 2010 Feb 4.

    PMID: 20133895RESULT

Related Links

MeSH Terms

Conditions

Multiple MyelomaBlood Coagulation DisordersHematologic DiseasesHemorrhagic DisordersHemostatic DisordersImmunoproliferative DisordersLymphoproliferative DisordersParaproteinemiasVascular Diseases

Interventions

dacetuzumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsCardiovascular DiseasesBlood Protein DisordersHemic and Lymphatic DiseasesImmune System DiseasesLymphatic Diseases

Study Officials

  • Nancy Whiting, PharmD

    Seagen Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 11, 2004

First Posted

March 16, 2004

Study Start

March 1, 2004

Primary Completion

August 1, 2007

Study Completion

November 1, 2007

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

US(5)