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Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGN-40
lenalidomide
dexamethasone
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Antigens, CD40, Antibodies, Monoclonal, Combined Modality Therapy, Multiple Myeloma, Blood Coagulation Disorders, Hematologic Diseases, Hemorrhagic Disorders, Hemostatic Disorders, Immunoproliferative Disorders, Lymphoproliferative Disorders, Paraproteinemias, Vascular Diseases, Antibody-Dependent Cell Cytotoxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of multiple myeloma.
  • Received at least one prior systemic therapy other than single-agent corticosteroids.
  • Measurable disease of monoclonal protein greater than or equal to 0.5 gram/dL in plasma or 0.5 gram/24 hr urine collection, or greater than 10 mg/dL free light chain (FLC) in serum as determined by serum FLC assay and provided the serum FLC ratio is abnormal.

Exclusion Criteria:

  • Received an allogenic stem cell transplant.
  • Previous intolerance of lenalidomide or dexamethasone.
  • Primary invasive malignancy (other than multiple myeloma) within the last 3 years.

Sites / Locations

  • Rocky Mountain Cancer Center
  • H. Lee Moffitt Cancer Center & Research Institute
  • Dana Farber Cancer Institute
  • Barbara Ann Karmanos Cancer Institute
  • Nebraska Methodist Hospital
  • Hackensack University Medical Center
  • Weill Medical College of Cornell University
  • Avera Cancer Institute
  • Baylor University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Adverse events and lab abnormalities.

Secondary Outcome Measures

Best clinical response, progression-free survival, and overall survival.
PK profile.
Anti-drug antibody immune responses.

Full Information

First Posted
August 31, 2007
Last Updated
October 7, 2014
Sponsor
Seagen Inc.
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00525447
Brief Title
Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple Myeloma
Official Title
A Phase I Study of SGN-40 (Anti-huCD40 mAb), Lenalidomide (Revlimid®, cc 5013), and Dexamethasone in Patients With Multiple Myeloma (MM)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase I, open-label, multi-dose trial to define the MTD and tolerability of a regimen including lenalidomide, dexamethasone, and intravenous SGN-40 in patients with relapsed multiple myeloma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Antigens, CD40, Antibodies, Monoclonal, Combined Modality Therapy, Multiple Myeloma, Blood Coagulation Disorders, Hematologic Diseases, Hemorrhagic Disorders, Hemostatic Disorders, Immunoproliferative Disorders, Lymphoproliferative Disorders, Paraproteinemias, Vascular Diseases, Antibody-Dependent Cell Cytotoxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SGN-40
Other Intervention Name(s)
dacetuzumab
Intervention Description
2-12 mg/kg IV (in the vein) on Days 1, 4, 8, 15, and 22 of Cycle 1; 4-12 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 of Cycles 2-4; 4-12 mg/kg IV (in the vein) on Days 1, 8, and 15 of Cycles 5-8.
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
Up to 25 mg daily of a 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
40 mg administered weekly.
Primary Outcome Measure Information:
Title
Adverse events and lab abnormalities.
Time Frame
Within 3 weeks of final infusion of SGN-40
Secondary Outcome Measure Information:
Title
Best clinical response, progression-free survival, and overall survival.
Time Frame
Study duration
Title
PK profile.
Time Frame
Within 3 weeks of final infusion of SGN-40
Title
Anti-drug antibody immune responses.
Time Frame
Within 3 weeks of final infusion of SGN-40

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of multiple myeloma. Received at least one prior systemic therapy other than single-agent corticosteroids. Measurable disease of monoclonal protein greater than or equal to 0.5 gram/dL in plasma or 0.5 gram/24 hr urine collection, or greater than 10 mg/dL free light chain (FLC) in serum as determined by serum FLC assay and provided the serum FLC ratio is abnormal. Exclusion Criteria: Received an allogenic stem cell transplant. Previous intolerance of lenalidomide or dexamethasone. Primary invasive malignancy (other than multiple myeloma) within the last 3 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Whiting, PharmD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

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Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple Myeloma

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