Multiple Myeloma Clinical Trial
Official title:
An Open-Label, Phase Ib, Dose-Escalation Study of the Safety and Pharmacology of the Anti-CD40 Monoclonal Antibody SGN-40 Administered in Combination With Bortezomib (Velcade®, PS-341) in Patients With Relapsed or Refractory Multiple Myeloma
NCT number | NCT00664898 |
Other study ID # | ACF4375g |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 2008 |
Est. completion date | April 8, 2010 |
Verified date | December 2022 |
Source | Genentech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label, multicenter, Phase Ib study to be conducted at approximately eight sites in Europe and the U.S. designed to evaluate the safety, pharmacokinetics, and activity of SGN-40 when combined with bortezomib in patients with multiple myeloma that is relapsed or refractory after at least one prior systemic treatment regimen.
Status | Completed |
Enrollment | 18 |
Est. completion date | April 8, 2010 |
Est. primary completion date | April 8, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Documented pathologic diagnosis of multiple myeloma that has relapsed or failed to respond after treatment with at least one prior systemic therapy (other than corticosteroid monotherapy) - Measurable disease - At least one prior systemic therapy other than single-agent corticosteroids - European Union patients must have had prior bone marrow transplant (autologous) or be ineligible for transplant - If previously received bortezomib, demonstration of clinical response of any duration or stable disease with progression-free interval of = 6 months from the start of that therapy - If previously received bortezomib, must have recovered from bortezomib-related toxicities and must have a peripheral neuropathy score of Grade = 1, according to the NCI CTCAE v3.0 - If applicable, completion of autologous transplant = 12 weeks prior to Day 1 - Discontinuation of previous anticancer or investigational therapy for = 21 days prior to treatment, or = 90 days prior to treatment for previous monoclonal antibody administration Exclusion Criteria: - Prior allogeneic bone marrow transplant - Other invasive malignancies within 3 years prior to Day 1 except for adequately treated basal cell or squamous cell skin cancer; carcinoma in situ of the cervix, breast, or prostate; or other cancer of which the patient has been disease-free for = 3 years - Prior anaphylactic reaction to human immunoglobulin administration - Symptomatic hyperviscosity syndrome - Active infection requiring parenteral antibiotics within 14 days of Day 1 - Major surgical procedure or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study - Clinically significant cardiac dysfunction or other significant organ dysfunction |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Genentech, Inc. | Seagen Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the maximum tolerated dose of SGN-40 when combined with bortezomib | Length of study | ||
Secondary | Determine safety, pharmacokinetics, and clinical response rate for combination therapy with SGN-40 and bortezomib | Length of study |
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