Clinical Trials

To participate in a Clinical Trial you must first contact your GP or specialist

For further information on ongoing publicly and privately supported clinical studies of human participants in Australian and New Zealand, please visit anzctr.org.au - the registry service of Australia and New Zealand.

Phase I

IST initiated a first in man Phase I clinical trial MDX-1097 (KappaMab) in June 2008 in patients with kappa type multiple myeloma. The study was conducted under the direction and supervision of Principal Investigator Professor Andrew Spencer, Head of Malignant Haematology and Stem Cell Transplant at The Alfred, Melbourne, Australia. The clinical trial was an open label phase I safety study of MDX-1097 in previously treated multiple myeloma patients with stable measurable disease. A single ascending dose of antibody was given to a total of 12 patients and the study was completed in December 2009. Results of the study can be seen at Spencer et al. 2010 JCO. ; ASCO 2010.

Phase IIa

IST completed a Phase IIa clinical trial of MDX-1097 (KappaMab) in patients with kappa type multiple myeloma in August 2012. The study was conducted at three sites in Australia under the direction and supervision of Principal Investigator Professor Andrew Spencer, Head of Malignant Haematology and Stem Cell Transplant at The Alfred, Melbourne. The clinical trial was an open label phase IIa study of the safety and efficacy of multiple doses of MDX-1097 in previously treated multiple myeloma patients with stable measurable disease. MDX-1097 was given once a week for eight weeks and a total of 19 patients completed the study. The antibody was shown to be safe and well tolerated and no dose limiting toxicities were observed. Details of the clinical trial results, including the results of response to treatment can be found at Dunn et al. 2013 Haematologica; Phase IIa.

Phase IIb

A Phase IIb clinical trial of KappaMab in combination with lenalidomide (Revlimid®) has been initiated at the Alfred Hospital, Melbourne Victoria. The study is entitled: A Phase IIb, open label, sequential cohort study comparing KappaMab in combination with lenalidomide and low dose dexamethasone (MRd) in Relapsed Refractory Multiple Myeloma.

Patients enrollment into the second stage of the Phase IIb clinical trail has started. 

The Principal Investigator is Prof Andrew Spencer, the Alfred Hospital is the study Sponsor and the clinical trial is partly funded by HaemaLogiX Pty Ltd and Celgene Pty Ltd.

This study is registered on the Australian New Zealand Clinical Trials Registery (ANZCTR); Trial ID - ACTRN12616001164482.

Information for patients and clinicians can be found at: anzctr.org.au.

Public queries should be directed to:

Ms Nola Kennedy (n.kennedy@alfred.org.au)

Alfred Health, Commercial Road, Melbourne, Victoria, 3004

Phone: +61 3 9076 2217

Scientific and clinical queries should be directed to:

Prof. Andrew Spencer (aspencer@netspace.net.au)

Alfred Health, Commercial Road, Melbourne, Victoria, 3004

Phone: +61 3 9076 3451

 

To read more about multiple myeloma, please click here.