Multiple MyelomaPhase 1NCT00079716
Study of SGN-40 in Patients With Refractory or Recurrent Multiple Myeloma
A Phase 1 study testing SGN-40 (anti-huCD40 mAb) in people with Multiple Myeloma, run by Seagen Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent. 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 (anti-huCD40 mAb)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2004to Nov 2007
- 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
- Patients must have refractory or recurrent secretory multiple myeloma (MM).
- Patients must have failed at least two different prior systemic therapies for MM.
- Patients may have received a maximum of five cytotoxic regimens.
- Patients who have received any of the following must complete within the specified time frame below:
- Autologous stem cell transplant - 12 weeks prior to first dose
- Nitrogen Mustard agents, Melphalan, BCNU, IVIG, or monoclonal antibody therapy - 6 weeks prior to first dose
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- Chemotherapy, Radiation, or other therapies for MM - 4 weeks prior to first dose
- Patients who have not undergone autologous stem cell transplantation must be either ineligible for stem cell transplantation or, if eligible, must have refused treatment by autologous stem cell transplantation.
- Patients must have an ECOG performance status of ≤ 2 and a life expectancy > three months.
- Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution for the entire duration of the study.
- Patients must be at least 18 years of age.
- Females of childbearing potential must have a negative β-HCG pregnancy test result within three days of enrollment. All patients must plan to use an effective contraceptive method during the course of the study.
- Patients must meet baseline lab data requirements.
- Patients must give written informed consent.
Who cannot join
- Patients with non-secretory MM or solitary plasmacytoma or plasma cell leukemia.
- Patients with a history of allogeneic transplantation.
- Patients receiving plasmapheresis within four weeks prior to enrollment.
- Patients undergoing major surgery within four weeks prior to enrollment.
- Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
- Patients with a history of other malignancies during the past five years with the exception of adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ.
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- Patients with any active viral, bacterial, or systemic fungal infection within four weeks of enrollment.
- Patients with a history of significant chronic or recurrent infections requiring treatment.
- Patients with a history of active thrombosis within three months of enrollment.
- Patients with a history of pulmonary embolism.
- Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment.
- Patients who are pregnant or breastfeeding.
- Patients with uncontrolled hypercalcemia.
- Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
- Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
The Cleveland Clinic
Cleveland, Ohio, 44195
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Cornell University
New York, New York, 10021
James R. Berenson M.D., Inc.
West Hollywood, California, 90069
About this study
Official title: A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Refractory or Recurrent Multiple Myeloma
The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent.
Read the detailed description
This is an open-label, multi-dose, single-arm, phase I, dose-escalation study to define the toxicity profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of SGN-40 in patients with refractory or recurrent multiple myeloma.
A minimum of three patients will be entered into each dose-level cohort. All patients will receive a dose-loading schedule during the first two weeks. The maximum weekly dose will be 16mg/kg.
- Conditions
- Multiple Myeloma
- Being tested
- SGN-40 (anti-huCD40 mAb)
- Keywords
- Antigens, CD40, Antibody, Monoclonal, 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-40 (anti-huCD40 mAb)Drug
Also called dacetuzumab
0.5-8 mg/kg IV (in the vein) on Day 1; 0-8 mg/kg on Day 4; 0.5-16 mg/kg on Days 8 and 15; 0-16 mg/kg on Day 29.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SGN-40 (anti-huCD40 mAb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and lab abnormalities.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2004 (estimated)
- Study startMar 2004
- Primary completionAug 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Investigators
- Nancy Whiting, PharmD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079716
- Sponsor's protocol ID
- SG040-0001
- Status last verified
- Dec 2014
- First submitted
- 11 Mar 2004
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hayashi T, Treon SP, Hideshima T, Tai YT, Akiyama M, Richardson P, Chauhan D, Grewal IS, Anderson KC. Recombinant humanized anti-CD40 monoclonal antibody triggers autologous antibody-dependent cell-mediated cytotoxicity against multiple myeloma cells. Br J Haematol. 2003 May;121(4):592-6. doi: 10.1046/j.1365-2141.2003.04322.x.
PubMed 12752100Hussein M, Berenson JR, Niesvizky R, Munshi N, Matous J, Sobecks R, Harrop K, Drachman JG, Whiting N. A phase I multidose study of dacetuzumab (SGN-40; humanized anti-CD40 monoclonal antibody) in patients with multiple myeloma. Haematologica. 2010 May;95(5):845-8. doi: 10.3324/haematol.2009.008003. Epub 2010 Feb 4.
PubMed 20133895
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Refractory or Recurrent Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00079716
- Acronym / sponsor ID
- SG040-0001
- Conditions
- Multiple Myeloma
- Keywords
- Antigens, CD40, Antibody, Monoclonal, Blood Coagulation Disorders, Hematologic Diseases, Hemorrhagic Disorders, Hemostatic Disorders, Immunoproliferative Disorders, Lymphoproliferative Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Mar 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 16 Mar 2004 (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.
The purpose of this study is to determine the safety and activity of SGN-40 in a weekly dosage schedule as a single agent.
Detailed description
This is an open-label, multi-dose, single-arm, phase I, dose-escalation study to define the toxicity profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of SGN-40 in patients with refractory or recurrent multiple myeloma.
A minimum of three patients will be entered into each dose-level cohort. All patients will receive a dose-loading schedule during the first two weeks. The maximum weekly dose will be 16mg/kg.
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 (anti-huCD40 mAb) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have refractory or recurrent secretory multiple myeloma (MM).
- Patients must have failed at least two different prior systemic therapies for MM.
- Patients may have received a maximum of five cytotoxic regimens.
- Patients who have received any of the following must complete within the specified time frame below:
- Patients who have not undergone autologous stem cell transplantation must be either ineligible for stem cell transplantation or, if eligible, must have refused treatment by autologous stem cell transplantation.
Key exclusion criteria (15 listed)
- Patients with non-secretory MM or solitary plasmacytoma or plasma cell leukemia.
- Patients with a history of allogeneic transplantation.
- Patients receiving plasmapheresis within four weeks prior to enrollment.
- Patients undergoing major surgery within four weeks prior to enrollment.
- Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
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-40 (anti-huCD40 mAb)Also: dacetuzumab0.5-8 mg/kg IV (in the vein) on Day 1; 0-8 mg/kg on Day 4; 0.5-16 mg/kg on Days 8 and 15; 0-16 mg/kg on Day 29. | Drug | 1 |
Primary outcome
Adverse events and lab abnormalities.
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 18 Dec 2014.
- Results publication: PubMed 12752100Hayashi T, Treon SP, Hideshima T, Tai YT, Akiyama M, Richardson P, Chauhan D, Grewal IS, Anderson KC. Recombinant humanized anti-CD40 monoclonal antibody triggers autologous antibody-dependent cell-mediated cytotoxicity against multiple myeloma cells. Br J Haematol. 2003 May;121(4):592-6. doi: 10.1046/j.1365-2141.2003.04322.x.
- Results publication: PubMed 20133895Hussein M, Berenson JR, Niesvizky R, Munshi N, Matous J, Sobecks R, Harrop K, Drachman JG, Whiting N. A phase I multidose study of dacetuzumab (SGN-40; humanized anti-CD40 monoclonal antibody) in patients with multiple myeloma. Haematologica. 2010 May;95(5):845-8. doi: 10.3324/haematol.2009.008003. Epub 2010 Feb 4.
- Related InfoLink provided by the sponsor.
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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.
5 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 (anti-huCD40 mAb) in people with Multiple Myeloma, run by Seagen Inc. at 5 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 14 inclusion and 15 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 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00079716, which also lists 2 linked publications.
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 18 Dec 2014.