Some of you are aware of the early stage clinical trial that has been testing the potential cancer vaccine, PVX-410, as active therapy for smoldering myeloma. The husband of Beacon columnist Tabitha Tow Burns has been enrolled in the trial, for example, and she has mentioned it in her columns.
Until now, the trial of PVX-410 has tested the vaccine only as single-agent therapy. Two doses were tested -- 0.4 mg and 0.8 mg.
Recently, however, the trial was expanded so that it now has a new arm that will be testing PVX-410 in combination with Revlimid. Patients who wish to enroll in the trial will only be able to enroll in the new arm of the trial, as the arm that is testing two different doses of the vaccine by itself is fully enrolled at the limit of 12 patients.
The new PVX-410 + Revlimid arm of the trial will enroll up to 10 patients, and one patient already has enrolled (so there are still 9 openings).
More information about the trial can be found at clinicaltrials.gov at the following link:
http://clinicaltrial.gov/ct2/show/NCT01718899
There are trial locations in the Boston area (Mass General, Dana Farber, and Beth Israel), Atlanta (Emory Winship), and Houston (MD Anderson).
Doris Peterkin, the CEO of OncoPep, which is the company developing PVX-410, wrote us recently to inform us of the new arm of the trial. She noted that results of the single-agent arm of the trial have led OncoPep to select the 0.8 mg dose as the target dose for further testing, with the drug having been found to be "safe and well tolerated at both doses."
If you have any questions about PVX-410 or the trial, feel free to post them here and we most likely will be able to get answers to them via representatives from OncoPep or the investigators involved with the trial.
Forums
4 posts
• Page 1 of 1
Re: New arm of PVX-410 vaccine trial for smoldering myeloma
For anyone who may be interested in this trial, we got an update about it last week from OncoPep. There continue to be openings in the Revlimid - PVX-410 arm of the trial.
More information about the trial can be found above. We also probably can get any questions readers may have about the trial answered by representatives from OncoPep or by the researchers conducting the trial.
(OncoPep is one of the pharmaceutical companies that has been kind enough to support the Beacon's efforts on behalf of the myeloma community.)
More information about the trial can be found above. We also probably can get any questions readers may have about the trial answered by representatives from OncoPep or by the researchers conducting the trial.
(OncoPep is one of the pharmaceutical companies that has been kind enough to support the Beacon's efforts on behalf of the myeloma community.)
Re: New arm of PVX-410 vaccine trial for smoldering myeloma
Hello Beacon,
Thank you for the information. I had already scheduled an appointment at Dana Farber to inquire on this trial but I have yet to hear back. I believe I qualify according to the eligibility information, but I was wondering if, because it is a "vaccine," immunoparesis or IVIG might be antagonistic to treatment? If I can get this answered without a trip to Boston, it would be much appreciated!
Also, are there any preliminary results on the existing 1/2 phase?
How do I message Beacon Advisers directly?
Best
J
Thank you for the information. I had already scheduled an appointment at Dana Farber to inquire on this trial but I have yet to hear back. I believe I qualify according to the eligibility information, but I was wondering if, because it is a "vaccine," immunoparesis or IVIG might be antagonistic to treatment? If I can get this answered without a trip to Boston, it would be much appreciated!
Also, are there any preliminary results on the existing 1/2 phase?
How do I message Beacon Advisers directly?
Best
J
-
jhorner - Name: Magpie
- Who do you know with myeloma?: Myself
- When were you/they diagnosed?: 2013
- Age at diagnosis: 49
Re: New arm of PVX-410 vaccine trial for smoldering myeloma
Hi jhorner,
We checked with OncoPep and immunoparesis would not disqualify you from participating in the trial. However, it would be best if you discussed your situation in more detail with someone involved with running the trial, as there may be further details that could affect your eligibility.
If you private message us with an email address or alternative means of contact, someone from Dana Farber who is involved with the trial will contact you very soon to discuss the particulars of your situation and whether you are likely to be eligible for the trial.
OncoPep also has informed us that they have not yet reported any efficacy results from the trial. However, they have reported that, thus far, there have not been any serious adverse events (safety issues).
We checked with OncoPep and immunoparesis would not disqualify you from participating in the trial. However, it would be best if you discussed your situation in more detail with someone involved with running the trial, as there may be further details that could affect your eligibility.
If you private message us with an email address or alternative means of contact, someone from Dana Farber who is involved with the trial will contact you very soon to discuss the particulars of your situation and whether you are likely to be eligible for the trial.
OncoPep also has informed us that they have not yet reported any efficacy results from the trial. However, they have reported that, thus far, there have not been any serious adverse events (safety issues).
4 posts
• Page 1 of 1