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Discussion about multiple myeloma treatments, stem cell transplants, clinical trials, alternative medicines, supplements, and their benefits and side effects.

Selinexor, Velcade, and dex or Kyprolis and dex?

by Canuck Bob on Wed May 18, 2016 4:11 pm

My multiple myeloma is back and requires new treatment. I've been off treatment for a couple of years. My doctors are recommending I consider two studies.

Option 1- "A phase 1B/2 study of selinexor (KPT-330) in combination with backbone treatments for relapsed/refractory multiple myeloma."

Backbone means Velcade (subcutaneous) / dex as well. This is newer but doctor has seen impressive response. It is also much less time consuming as I work and have young teen daughters.

Option 2- "Phase 3 study receiving carfilzomib (Kyprolis) in combination with dex, comparing once-weekly versus twice-weekly carfilzomib dosing."

This one requires IV treatment and after random selection I would have Kyprolis infusions either once or twice weekly.

Anyone have anything to share please? A quick decision is prudent.
Last edited by Canuck Bob on Wed May 18, 2016 5:18 pm, edited 2 times in total.

Canuck Bob
Name: Bob
Who do you know with myeloma?: Myself
When were you/they diagnosed?: Feb. 2011
Age at diagnosis: 57

Re: Selinexor, Velcade, and dex or Kyprolis and dex?

by Mark Pouley on Wed May 18, 2016 4:22 pm

I don't have a lot of information that will help your final decision, but I have been using carfilzomib (Kyprolis) in combination with Pomalyst and dex since January 16. Previously I tried Revlimid, Velcade and dex and stopped responding after 4 cycles. I've responded very well and had little to no side effects.

Mark Pouley
Name: Mark
Who do you know with myeloma?: Self
When were you/they diagnosed?: April 2015
Age at diagnosis: 53

Re: Selinexor, Velcade, and dex or Kyprolis and dex?

by Canuck Bob on Wed May 18, 2016 4:52 pm

Thanks, I have been Google searching diligently, surely the definition of both blessing and curse!

Canuck Bob
Name: Bob
Who do you know with myeloma?: Myself
When were you/they diagnosed?: Feb. 2011
Age at diagnosis: 57

Re: Selinexor, Velcade, and dex or Kyprolis and dex?

by HobGlobulin on Wed May 18, 2016 5:04 pm

My experience so far (since early April) in a Kyprolis / Revlimid / dex trial has been very good as well. No negative side effects for me from the higher dosage.

HobGlobulin

Re: Selinexor, Velcade, and dex or Kyprolis and dex?

by Jonah on Wed May 18, 2016 5:04 pm

Hi Bob,

A few questions that I think are probably relevant to your decision:

  1. Would you still be eligible for the Kyprolis trial if you do the selinexor trial first? (The answer to that question probably depends on eligibility requirements for the Kyprolis trial AND how full the trial is right now.)
  2. Have you been treated with Velcade already?
  3. Could you be treated right now with Kyprolis outside of a trial? If not, will that change in the near future?

Jonah

Re: Selinexor, Velcade, and dex or Kyprolis and dex?

by Canuck Bob on Wed May 18, 2016 5:31 pm

I have asked this of the clinical nurse.

Selinexor is leading at this time.

I was on Velcade / dex pre-transplant. Revlimid post-transplant for 2 years, hated the stuff.

I don't think Kyprolis is approved yet in Canada.

Canuck Bob
Name: Bob
Who do you know with myeloma?: Myself
When were you/they diagnosed?: Feb. 2011
Age at diagnosis: 57

Re: Selinexor, Velcade, and dex or Kyprolis and dex?

by Nancy Shamanna on Wed May 18, 2016 6:49 pm

Hi Canuck Bob, You are right that Kyprolis is not yet approved in Canada, but it is in the CADTH process now (approval by an oncology review), and if it passes that, will get the panCanadian pricing done. I think that we should soon be able to advocate for its inclusion into our provincial formularies, and that it will be available to myeloma patients So right now it is still available thru clinical trials. I don't think that selinexor is near that level of approvals yet though. That clinical trial is phase 1b/2, whereas the Kyprolis is a phase 3 trial. Health Canada will only accept applications from drugs with phase 3 trials. Hope that helps!

Nancy Shamanna
Name: Nancy Shamanna
Who do you know with myeloma?: Self and others too
When were you/they diagnosed?: July 2009

Re: Selinexor, Velcade, and dex or Kyprolis and dex?

by TerryH on Wed May 18, 2016 6:57 pm

Actually, Kyprolis IS approved in Canada. It has received the required regulatory approval to be administered outside of clinical trials:

https://myelomabeacon.org/forum/kyprolis-approved-in-canada-t6649.html

It may not yet have reimbursement approval in most (all?) Canadian provinces. But that is a separate issue, and it is not what is traditionally meant when you speak about whether a drug has been "approved" or not in a country. That question almost always refers to marketing (regulatory) approval.

TerryH

Re: Selinexor, Velcade, and dex or Kyprolis and dex?

by Nancy Shamanna on Wed May 18, 2016 7:01 pm

Hi TerryH, I stand corrected on that. If you had the type of private insurance such as Sunlife or Greatwest Life that might cover Kyprolis without having to get it funded by one's province, it could be available. What I meant was that we are waiting for it to be funded by our public health care system, which is decided by each province.

Nancy Shamanna
Name: Nancy Shamanna
Who do you know with myeloma?: Self and others too
When were you/they diagnosed?: July 2009

Re: Selinexor, Velcade, and dex or Kyprolis and dex?

by Jonah on Wed May 18, 2016 9:25 pm

Hi Bob,

Because you probably will have access to Kyprolis outside of a clinical trial by maybe later this year, or perhaps even earlier, I think it might be worth going with the selinexor trial at this point.

You probably won't have a really deep response to the selinexor, Velcade, and dex combination, given that you've already had Velcade. But early trial results suggest that selinexor does have anti-myeloma activity. By trying the drug now, you make sure you have a chance to try it at some point.

Because selinexor is a number of years away from approval as a myeloma treatment, you may not have a chance to be treated with it later if you don't try it now.

You can search for myeloma trials in Canada by going to clinicaltrials.gov's advanced search page,

https://clinicaltrials.gov/ct2/search/advanced

and typing "myeloma" into the "Conditions" field, and then selecting down below the province that you are in. After you hit the search button, you can press another button to show just trials that are actively recruiting patients.

Good luck, and let us know what you decide and why.

Jonah

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