Canadian Apheresis Group

Update on Clinical Trials December 2005

Surveillance Study

A letter was sent to all centres participating in the Viral Surveillance Study on July 21, 2005 announcing that the study will stop entry of new patients as of August 01, 2005.

To date, a total of 301 patients have been entered into the study which involves a 6 month follow up. Dr. Tony Giulivi was involved with this study representing Health Canada and has arranged to have the samples tested for various viruses at the Winnipeg Viral Lab. As soon as the results from these samples are available, we will prepare a report which will be shared with all centers.

If you have any patients already entered into the study, please try to ensure that the 6 month follow up does occur and you will be reimbursed for those patients at that time. We ask that you fax the patient/sample information to the CAG office but SEND THE SAMPLES DIRECTLY TO THE WINNIPEG VIRAL LAB ON MONDAY, TUESDAY OR WEDNESDAY. Please do not ship on Thursday and Friday as the samples may not be delivered on time and will sit in a warehouse over the weekend. The shipping address is as follows:

Dr. Anton Andonov
National Microbiology Laboratories
Canadian Science Centre for Human and Animal Health
Arlington St., Suite 4800
Winnipeg, MB R3E 3R2

Myeloma Study
Dr. Clark et al. published their Myeloma study which concluded that at enrolment, the plasma exchange and control groups were similar for dialysis dependence, chemotherapy, gender, age, hypercalcemia, serum albumin, 24-hour urine protein, serum creatinine and Durie-Salmon staging. The primary composite endpoint occurred in 33/57 (57.9%) of the plasma exchange group and in 27/39 (69.2%) of the control group (difference between groups 11.3%, 95% confidence interval -8.3% to 29.1%, p=0.36) . One-third of the patients in each group died.

The study was small, used a composite outcome, and did not use renal biopsy as an inclusion criterion. Recruiting physicians were blinded to treatment allocation but not to treatment thereafter.

Conclusions: In patients with acute renal failure at the onset of multiple myeloma, there is no conclusive evidence that 5 to 7 plasma exchanges provides a substantial benefit in reducing a composite outcome of death, dialysis dependence or GFR < 30 ml/min/1.73m2 at 6-months.

Pentaspan
The Pentaspan Protocol is completed. Unfortunately, Bristol-Myers Squibb is reluctant to support CAG in a clinical trial at this time. We are looking for solutions.

Voluven®
In Europe, Fresenius Kabi has introduced Voluven® 6% (hydroxyethylstarch) solution for infusion, as a blood volume expander. The company says that Voluven® has the same volume expansion effect as its HAES-Steril intravenous infusion, but has a lower molecular weight, a lower degree of substitution on the molecule and fewer side effects.

Proposed New Trial: Uniplas
As a follow-up to the Annual Meeting information, Octapharma submitted the TTP trial proposal to the US FDA and is in the process of responding to the FDA’s questions. It is expected that the resubmission will occur in December. As soon as FDA approval is gained, Octapharma will start the submission to Health Canada and we hope to be able to begin the new trial before long.

Did you know??

Octaplas (another product manufactured by Octapharma in Vienna) is a frozen product which is licensed for use in Canada. Octaplas possesses the same clinical activity as normal human FFP. After Solvent Detergent (SD) treatment and subsequent removal of the SD reagents, the plasma protein content and distribution in Octaplas remain at comparable levels to those in FFP, i.e. 45-70 mg/ml. The coagulation activity values are close to the corresponding values for normal human FFP and a minimum of 0.5 IU/ml is obtained for each coagulation factor. The finished product is tested for coagulation factors V, VIII, XI. However, as a result of the SD treatment and purification, the content in lipids and lipoproteins is reduced. The shelf-life of Octaplas is two years when stored at < -30oC and protected from light. Once the bag has been opened, the product must be used immediately, within one hour after thawing.