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A Phase II study of Æ-941 in refractory and early relapse multiple myeloma patients


 About the trial:

This Phase II clinical trial has been designed to obtain accelerated approval of Neovastat in the treatment of multiple myeloma patients with refractory disease. The study will determine tumor response based upon commonly used criteria, such as the level of M-protein (myeloma protein). Other parameters specific to the disease will also be considered. The trial seeks to establish that 20% of patients that receive Neovastat will experience tumor response. The study will involve approximately 35 sites across North America and Europe, and will evaluate the efficacy of Neovastat as monotherapy treatment for patients with multiple myeloma not responding to standard therapies. Approximately 125 patients are to be included and the final results of the trial are expected in early 2003.

Study Synopsis:

Objective:  

To determine the confirmed tumor response rate of patient with refractory and early relapse Multiple Myeloma (MM) within 36 weeks of treatment with Æ-941 (120 mL b.i.d.)

Design:       

A multi-center, single-arm, open label, one-stage, Phase II trial.

Treatment: 

120 mL b.i.d. of Æ-941 as only anti-cancer treatment until disease progression. Concomitant administration of biosphosphonates and treatment with erythropoietin will be allowed.

Patient population:

a. Has had a PD (following, CR, R or PR) < 6 months following the end of first-line chemotherapy with or without stem cell transplantation (STC)

OR

b. Has had relapse (following CR, R or PR) after the end of previous chemotherapy regimen, following which patient has had less than a PR while on salvage chemotherapy, with or without STC. Patients who have received thalidomide ≤ 3 months and have stable disease whose treatment discontinued due to drug intolerance or toxicity, will be eligible should all other criteria be fulfilled

OR

c. Has had SD following first-line chemotherapy with STC

Number of subjects:      

125

Efficacy endpoints:        

Tumor response (primary)

Time to progression, duration of tumor response and survival (exploratory)

Definition of primary endpoint:        

Tumor response definition according to the South Western Oncology Group (SWOG). Remission includes complete remission, remission and partial remission.

Tumor responses will be required to be confirmed 8 to 10 weeks after the criteria for response are first met.

Statistical analysis

All primary efficacy analyses will be based on the per-protocol analysis population. Primary efficacy analyses will also be performed on the intent-to-treat population for sensitivity purposes. Unless there is a significant discrepancy between the intent-to-treat and per-protocol populations, the exploratory endpoint will be summarized on an intent-to-treat basis. All safety analyses will be performed on the intent-to-treat population.

 
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