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OpenTrials
Completed

NCT Number: NCT00525447

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

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.

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Key information

Conditions

Multiple Myeloma Blood Coagulation Disorders Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rocky Mountain Cancer Center, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SGN-40

Drug

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.

Other names: dacetuzumab

Lenalidomide

Drug

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

Other names: Revlimid

Dexamethasone

Drug

40 mg administered weekly.

Other names: Decadron

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

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Collaborators

  • Genentech, Inc.

Registry information

Official study title

A Phase I Study of SGN-40 (Anti-huCD40 mAb), Lenalidomide (Revlimid®, cc 5013), and Dexamethasone in Patients With Multiple Myeloma (MM)

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 5, 2007
Registry last updated
Oct 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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