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.
- Conditions
- M. KahlerPlasma Cell dyscrasia10035227
- Registration Number
- NL-OMON31502
- Lead Sponsor
- Genentech
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 26
• 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, defined as follows:
Serum M-protein >= 1 g/dL (>= 10 g/L)
Urine M-protein >= 200 mg/24 hr urine collection
Involved FLC level >= 10 mg/dL (>= 100 mg/L, provided serum FLC ratio is abnormal)
• 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 (note: the requirement for prior transplant is based on the approved indication for bortezomib in the European Union at the time the protocol was finalized).
• 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
• ECOG performance status of 0 or 1 (see Appendix F)
• Life expectancy of > 3 months
• Prior treatment with a monoclonal antibody directed against CD40
• Prior allogeneic bone marrow transplant
• Concurrent systemic corticosteroid therapy (except corticosteroid therapy <= 20 mg/day prednisone or equivalent used to treat an illness other than lymphoma)
• clinical laboratory values:
ANC < 1000/µL
Platelet count < 75,000/µL
Total bilirubin > 1.6 mg/dL AST or ALT greater than the upper limit of normal (ULN) Serum creatinine > 1.5 times upper limit of normal or calculated creatinine
clearance < 50 mL/min
Hemoglobin < 9 g/dL (may be transfused to maintain or exceed this level) ;• 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
• Known intracranial disease or epidural disease
Patients with lytic lesions of the cranium secondary to myeloma are eligible to enroll.
• 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
• Serious, nonhealing wound, ulcer, or bone fracture
• Clinically significant cardiac disease (New York Heart Association, Class III or IV), including preexisting arrhythmia, congestive heart failure, or cardiomyopathy
• Any contraindication to bortezomib treatment, including hypersensitivity to bortezomib, boron, or mannitol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Occurrence and nature of DLT</p><br>
- Secondary Outcome Measures
Name Time Method