Trial Name
Anti-CD66 - A randomised Phase II Clinical Trial using Targeted Radiotherapy delivered by an Yttrium-90 Radio-labelled Anti-CD66 Monoclonal Antibody with high dose melphalan compared to melphalan alone, prior to Autologous Stem Cell Transplantation for Multiple Myeloma.
Description
A randomised phase II trial comparing two transplant conditioning schedules prior to autologous stem cell transplantation in patients with multiple myeloma.
Objectives
Primary Objective:
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To determine the efficacy of targeted radiotherapy delivered by an Yttrium-90 (90Y)-radiolabelled murine anti-CD66 monoclonal antibody, given in addition to high dose melphalan (200mg/m2) in terms of disease response (complete remission rate and change of serum free light chain level pre and post Yttrium-90-radiolabelled anti-CD66) in patients undergoing HSCT for multiple myeloma.
Secondary Ojective:
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To determine the toxicity profile of 90Y-radiolabelled anti-CD66 MAb in the context of autologous stem cell transplantation.
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To determine the effect of targeted radiotherapy on other parameters of disease response, e.g. proportion of patients with partial remission (PR), stable disease (SD), progressive disease (PD), remission duration (time to disease progression) and overall survival (OS).
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To determine the effect of targeted radiotherapy on engraftment when used in conjunction with high dose melphalan in patients undergoing autologous peripheral blood stem cell transplantation as treatment for multiple myeloma.
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To investigate the pharmacokinetic (PK) behaviour of Indium-111 (111In) radiolabelled anti-CD66 MAb, (used for dosimetry) in man.
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To continue to develop a dosimetry model based on SPECT/CT and whole body gamma camera imaging following administration of the radiolabelled anti-CD66 MAb.
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To assess the proportion of patients that form human anti-murine antibodies (HAMA) following exposure to anti-CD66 MAb in the context of an autologous stem cell transplant.
Design
A randomised, non-blind Phase II study with two treatment arms comparing two transplant conditioning schedules prior to autologous stem cell rescue:
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Arm ‘A’: high dose melphalan (200mg/m2) plus targeted radiotherapy.
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Arm ‘B’: high dose melphalan (200mg/m2) alone.
Status
Complete
Population
80 Patients with multiple myeloma scheduled for autologous stem cell transplantation recruited from three treatment centres and randomised in a 1:1 fashion.
Contact details
All Trial enquiries should be addressed to
[email protected]