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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose of SGN-40 when combined with bortezomib

Outcome Time Frame:

Length of study

Safety Issue:

No

Principal Investigator

Sandra Skettino, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

ACF4375g

NCT ID:

NCT00664898

Start Date:

May 2008

Completion Date:

April 2010

Related Keywords:

  • Multiple Myeloma
  • anti-CD40
  • Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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