NCT00525447

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

9 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

August 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

2.4 years

First QC Date

August 31, 2007

Last Update Submit

October 7, 2014

Conditions

Multiple Myeloma

Keywords

Antigens, CD40Antibodies, MonoclonalCombined Modality TherapyMultiple MyelomaBlood Coagulation DisordersHematologic DiseasesHemorrhagic DisordersHemostatic DisordersImmunoproliferative DisordersLymphoproliferative DisordersParaproteinemiasVascular DiseasesAntibody-Dependent Cell Cytotoxicity

Outcome Measures

Primary Outcomes (1)

  • Adverse events and lab abnormalities.

    Within 3 weeks of final infusion of SGN-40

Secondary Outcomes (3)

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

    Study duration

  • PK profile.

    Within 3 weeks of final infusion of SGN-40

  • Anti-drug antibody immune responses.

    Within 3 weeks of final infusion of SGN-40

Study Arms (1)

1

EXPERIMENTAL
Drug: SGN-40Drug: lenalidomideDrug: dexamethasone

Interventions

SGN-40DRUG

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
1
lenalidomideDRUG

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

Also known as: Revlimid
1
dexamethasoneDRUG

40 mg administered weekly.

Also known as: Decadron
1

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Multiple MyelomaBlood Coagulation DisordersHematologic DiseasesHemorrhagic DisordersHemostatic DisordersImmunoproliferative DisordersLymphoproliferative DisordersParaproteinemiasVascular Diseases

Interventions

dacetuzumabLenalidomideDexamethasoneCalcium Dobesilate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2007

First Posted

September 5, 2007

Study Start

August 1, 2007

Primary Completion

January 1, 2010

Study Completion

February 1, 2010

Last Updated

October 9, 2014

Record last verified: 2014-10

Locations

US(9)