Multiple MyelomaPhase 1NCT00525447
Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple Myeloma
A Phase 1 study testing SGN-40, lenalidomide and dexamethasone in people with Multiple Myeloma, run by Seagen Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- SGN-40, lenalidomide and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2007to Feb 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Received an allogenic stem cell transplant.
- Previous intolerance of lenalidomide or dexamethasone.
- Primary invasive malignancy (other than multiple myeloma) within the last 3 years.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Baylor University Medical Center
Dallas, Texas, 75246
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Weill Medical College of Cornell University
New York, New York, 10021
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase I Study of SGN-40 (Anti-huCD40 mAb), Lenalidomide (Revlimid®, cc 5013), and Dexamethasone in Patients With Multiple Myeloma (MM)
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.
- Conditions
- Multiple Myeloma
- Being tested
- SGN-40, lenalidomide, dexamethasone
- 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
- Medical subject headings
- Multiple Myeloma, Blood Coagulation Disorders, Hematologic Diseases, Hemorrhagic Disorders, Hemostatic Disorders, Immunoproliferative Disorders, Lymphoproliferative Disorders, Paraproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-40Drug
Also called dacetuzumab
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.
lenalidomideDrug
Also called Revlimid
Up to 25 mg daily of a 21-day cycle.
dexamethasoneDrug
Also called Decadron
40 mg administered weekly.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SGN-40; Drug: lenalidomide; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and lab abnormalities.
Measured: Within 3 weeks of final infusion of SGN-40
Secondary outcomes (3)
Best clinical response, progression-free survival, and overall survival.
Measured: Study duration
PK profile.
Measured: Within 3 weeks of final infusion of SGN-40
Anti-drug antibody immune responses.
Measured: Within 3 weeks of final infusion of SGN-40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Nancy Whiting, PharmD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525447
- Sponsor's protocol ID
- SG040-0006
- Status last verified
- Oct 2014
- First submitted
- 31 Aug 2007
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of SGN-40 (Anti-huCD40 mAb), Lenalidomide (Revlimid®, cc 5013), and Dexamethasone in Patients With Multiple Myeloma (MM)
- ClinicalTrials.gov ID
- NCT00525447
- Acronym / sponsor ID
- SG040-0006
- Conditions
- Multiple Myeloma
- Keywords
- Antigens, CD40, Antibodies, Monoclonal, Combined Modality Therapy, Multiple Myeloma, Blood Coagulation Disorders, Hematologic Diseases, Hemorrhagic Disorders, Hemostatic Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SGN-40, Drug: lenalidomide, Drug: dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Received an allogenic stem cell transplant.
- Previous intolerance of lenalidomide or dexamethasone.
- Primary invasive malignancy (other than multiple myeloma) within the last 3 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGN-40Also: dacetuzumab2-12 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. | Drug | 1 |
| lenalidomideAlso: RevlimidUp to 25 mg daily of a 21-day cycle. | Drug | 1 |
| dexamethasoneAlso: Decadron40 mg administered weekly. | Drug | 1 |
Primary outcome
Adverse events and lab abnormalities.
Time frame: Within 3 weeks of final infusion of SGN-40
3 secondary outcomes
Best clinical response, progression-free survival, and overall survival.
Time frame: Study duration
PK profile.
Time frame: Within 3 weeks of final infusion of SGN-40
Anti-drug antibody immune responses.
Time frame: Within 3 weeks of final infusion of SGN-40
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Whiting, PharmD study director
Seagen Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGN-40, lenalidomide and dexamethasone in people with Multiple Myeloma, run by Seagen Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and lab abnormalities. (time frame: Within 3 weeks of final infusion of SGN-40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.