Month: September 2005

Next, please?

I got my last infusion of CNTO 320 a week ago Tuesday. The drug was free of any noticeable side effects. About the only thing I noticed was an increase in cholesterol and triglycerides. It’s not certain what effect the treatment is having on my MM though. This was a phase I trial, so we’re the first humans to get the drug. The doctors think that it may take a while for it to work, so it could be a wait and see situation. I’m not sure how long we’ll wait though. I have a bone marrow biopsy, labs and xrays next week so we’ll see how that goes. I’ve been disappointed in my labs so far though. Before the first infusion, my IgA was in the 1600s. Last week, it was in the 2100s. If the next reports show an improvement or stable disease, I can qualify for more. If not, it’s time to try something else.

Here’s where the difficult choice needs to be made. I can do another trial at UNC. There’s one that I talked about before: Velcade vs Velcade + Doxil. That’s a harsher treatment than I’ve ever had before. It could worsen my PN. Maybe not though. I won’t know until I try it.

FDA panel backs Celgene’s Revlimid

BOSTON — A Food and Drug Administration advisory panel has voted to recommend that the agency approve Celgene Corp.’s oncology drug Revlimid, the company said Wednesday.

By Val Brickates Kennedy, MarketWatch
Last Update: 1:19 PM ET Sept. 14, 2005

Trading in shares of Summit, N.J.-based Celgene was halted at $52.91
Wednesday morning, ahead of the meeting. Celgene is seeking to have the drug Revlimid approved for the treatment of transfusion-dependent anemia due to certain blood cancers known as myelodysplastic syndromes.

Although the panel’s vote is not a final decision, the FDA traditionally
abides by the recommendation of its expert panels.

Celgene said that the FDA is scheduled to formally rule on whether to
approve Revlimid by Oct. 7. The company already markets a version of thalidomide called Thalomid, for the treatment of leprosy, and Alkeran, a treatment for the cancer multiple myeloma.

Trial

I’m on the CNTO 328 trial, as you know. So far, I’m not sure what to make of the results. My IgA was in the 1600s at the start, then went to the 1800s. Last week it was 2411. Yesterday it was 2052. I suppose we won’t really know whether it’s helped or not until the trial is complete. I have infusion #4 on Tuesday. A few weeks later, there’ll be another bone marrow biopsy and some bloodwoork. I hope it does end up working. I’ve been told it could work very slowly, so my IgA could go down.