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CompletedNCT00525447Updated Oct 9, 2014

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

A Phase 1 interventional study of SGN-40 and lenalidomide in Multiple Myeloma, sponsored by Seagen Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-09.

Sponsored by Seagen Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 36 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Seagen Inc. is the lead sponsor of 84 studies on the registry; 1 is open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    1

    Drug: SGN-40 · Drug: lenalidomide · Drug: dexamethasone

Interventions

  • DrugSGN-40

    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.

    Also known as: dacetuzumab

  • Druglenalidomide

    Up to 25 mg daily of a 21-day cycle.

    Also known as: Revlimid

  • Drugdexamethasone

    40 mg administered weekly.

    Also known as: Decadron

06

What researchers measure

Primary outcomes

  1. Adverse events and lab abnormalities.

    Time frame: Within 3 weeks of final infusion of SGN-40

Secondary outcomes

  1. Best clinical response, progression-free survival, and overall survival.

    Time frame: Study duration

  2. PK profile.

    Time frame: Within 3 weeks of final infusion of SGN-40

  3. Anti-drug antibody immune responses.

    Time frame: Within 3 weeks of final infusion of SGN-40

07

Study locations

9 sites
  • Rocky Mountain Cancer Center
    Denver, Colorado 80218, United States
  • H. Lee Moffitt Cancer Center & Research Institute
    Tampa, Florida 33612, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Nebraska Methodist Hospital
    Omaha, Nebraska 68114, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Weill Medical College of Cornell University
    New York, New York 10021, United States
  • Avera Cancer Institute
    Sioux Falls, South Dakota 57105, United States
  • Baylor University Medical Center
    Dallas, Texas 75246, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00525447
Lead sponsor
Seagen Inc.
Collaborators
Genentech, Inc.
Responsible party
Sponsor
First posted
Sep 5, 2007
Start date
Aug 2007
Primary completion
Jan 2010
Completion
Feb 2010
Last update
Oct 9, 2014

Study contacts

Nancy Whiting, PharmD
study director · Seagen Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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