Open randomised phase II study evaluating the anti-tumour activity, safety and pharmacology of two different dose regimens of IPH 2101, a human monoclonal anti-KIR antibody, in patients with multiple ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-012136-33

Open randomised phase II study evaluating the anti-tumour activity, safety and pharmacology of two different dose regimens of IPH 2101, a human monoclonal anti-KIR antibody, in patients with multiple myeloma in stable partial response after a first line therapy

Femme et Homme

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Extrait

The primary objective is to evaluate the clinical activity, measured by M-protein serum and urine levels, of two different dose regimens (0.2 mg/kg, leading to an intermittent saturation of NK receptors and 2mg/kg leading to a sustained saturation of NK receptors) of IPH2101 administered as a single agent in multiple myeloma patients who achieved, after the completion of any first line treatment, including conventional or high dose chemotherapies, a partial or very good partial response (PR or VGPR), stable for at least 2 months.


Critère d'inclusion

  • Multiple myeloma

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