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Open Label Study of the Anti Insulin-like Growth Factor 1 Receptor (IGF-1R) Monoclonal Antibody, AVE1642, as Single Agent (Dose Escalation, Part 1) and in Combination With VelcadeĀ® (Combination, Part 2) in Patients With Recurrent, Refractory Multiple Myeloma (MM)


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

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Trial Information

Open Label Study of the Anti Insulin-like Growth Factor 1 Receptor (IGF-1R) Monoclonal Antibody, AVE1642, as Single Agent (Dose Escalation, Part 1) and in Combination With VelcadeĀ® (Combination, Part 2) in Patients With Recurrent, Refractory Multiple Myeloma (MM)


Inclusion Criteria:



- Multiple myeloma confirmed by bone marrow aspirate or biopsy

- Patient had to have relapsed and/or refractory multiple myeloma after at least 1
standard therapy, and have demonstrated disease progression

- Previous exposure to Velcade was allowed, provided no DLTs of Grade 3 or above had
been observed during previous treatment (for Part 2 of the study only)

Exclusion Criteria:

- Prior therapy with any IGF-1 system targeting compound

- History of allogenic stem cell transplantation in case of concomitant
immunosuppressive therapy within 6 months before study entry. Patients having
undergone autologous stem cell transplantation(s) may have been included in the study

- History of organ transplant and any patient receiving long term systemic
immunosuppressive therapy

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

definition of the Selected Dose (SD)

Outcome Description:

Selected Dose will be based on the AVE1642 clearance /IGF-1 plateaus and on safety (less than 33% of pts with dose limiting toxicity (DLT)when administered as single agent in a first part of the study. The safety and pharmacokinetics of the regimen in combination with bortezomib will be assessed in the second part of the study

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

France: Institutional Ethical Committee

Study ID:

TED6420

NCT ID:

NCT01233895

Start Date:

September 2006

Completion Date:

September 2008

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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