Status:
COMPLETED
A Study of the Safety and Pharmacology of SGN-40 Administered in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Seagen Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00664898
Start Date
May 1 2008
End Date
April 8 2010
Last Update
December 12 2022
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