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Are New Treatments Available to Smoldering Myeloma Patients?

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Published on February 8, 2016

Dr. Robert Orlowski responds to a question from a Patient Power community member related to access to newly approved treatments for smoldering myeloma patients. Listen as Dr. Orlowski provides an explanation of smoldering myeloma, including the current standard of care, and goes on to discuss possible with new therapies as well as the ins and outs of participating in a clinical trial.

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daratumumab

elotuzumab

This Ask the Expert series is sponsored by the Patient Empowerment Network, which received funding from Celgene, Novartis and Takeda.

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Transcript | Are New Treatments Available to Smoldering Myeloma Patients?

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

Andrew Schorr:

I’m going to read this question that came in from Michelle.  So she has smoldering myeloma, trying to get educated.  Great, Michelle.  “And I see repeatedly that the first line of therapy is usually your best shot at fighting the cancer.  But if I understand correctly, the recently FDA-approved myeloma drugs are not for newly diagnosed patients,” maybe clarify that.  “So does that mean that newly diagnosed patients cannot get the new drugs?”  Because she wants to fight it up front, right?  Or are they limited only in clinical trials?  So how does this reconcile with the fact that the first line of therapy has the greatest impact? 

Dr. Orlowski:     

Well, thanks very much for that question, Michelle, which I think is very important.  First of all, since we know from her comment that she has smoldering myeloma, one thing that’s important to remember is that the criteria for how to differentiate smoldering myeloma, which we still don’t treat, versus symptomatic myeloma, which we do treat, has recently changed.  And so it’s important to make sure that she talks with her physician and hopefully a myeloma expert to make sure that she is still smoldering or possibly that she has active myeloma. 

And just briefly, the new criteria are if you have bone marrow involvement of 60 percent or more with myeloma, that’s now symptomatic myeloma, not smoldering.  If you have an MRI with more than one focal bone lesion, that’s symptomatic disease.  And also if your free light chain ratio involved to uninvolved is 100 or more, that is symptomatic disease as well.  Hopefully, she doesn’t have any of those and is still smoldering.  Right now the standard of care for smoldering is still a watch-and-wait approach. But because many of the drugs we’ve talked about, like daratumamab (Darzalex) and elotuzumab (Empliciti), are very well tolerated, people are looking at the possibility that these could be used in the smoldering setting. 

So she should look for clinical trials to determine if possibly she could be eligible for them.  In terms of her specific question, the new drugs that we’ve talked about right now are predominantly approved in the relapsed setting for people with one to three prior lines of therapy.  So we usually think that once a drug is approved there it is possible to use it earlier for newly diagnosed myeloma.  The problem is that if it isn’t approved for front-line therapy, insurance may not cover it. And so if she wants to use one of those drugs, she may have to look for a clinical trial. 

Andrew Schorr:                  

Oh, my.  Okay, so that’s complicated as to what is the right—you want to have your best shot for fighting the cancer.  Okay, so what do you tell people then just—you mentioned about clinical trials, I just want to get to that for a second is, with things changing, and you mentioned about insurance, some things being available in clinical trials you’re looking at combinations, should that be a very active discussion now for myeloma patients to participate in clinical trials?  Is there a trial that’s right for me?  Could it give me a bigger bang, if you will?

Dr. Orlowski:     

That’s a great question.  And even though we’ve had these five approvals and more drugs are coming, we need to continue to enroll patients onto clinical trials, because there are many more exciting drugs that look like they’re active.  And the sooner we understand how active, the easier we’ll get to the point that maybe we’ll even be curing patients.  So it is important for folks to talk to their doctors about not just what standard options they have, but also about maybe what clinical trials are available.  The advantage to clinical trials is that you have access to new drugs, oftentimes they are things that are not yet approved, but that we know work in myeloma.  Typically they’re provided for free, although the standard part of it does sometimes get billed to insurance. 

Andrew Schorr:                  

And there are tests and other things that get billed as well. 

Dr. Orlowski:     

Of course.  And most of those are considered standard of care and would be billed to insurance.  If there’s any test which is done only from the trial perspective, that usually is covered, but it’s always a good discussion to have with either the doctor or the nurse or other healthcare provider. 

Andrew Schorr:                  

Okay, and here’s another question I just had is, you have an oral proteasome inhibitor approved, and I know people have been wondering this, and you’ve had bortezomib (Velcade) and Kyprolis, I think, or carfilzomib, is an injected or infused proteasome inhibitor.  Well, if somebody’s on one of those drugs, should they switch simply for convenience and is it as effective?

Dr. Orlowski:     

Well, the approval for ixazomib (Ninlaro), which is the oral proteasome inhibitor, is for people who’ve had one or more prior lines of therapy.  And so that does allow patients to think about switching over.  But right now, we don’t have any experience as to how well that works.  So the advantage of the ixazomib is it’s oral, very convenient, you don’t have to schlep into the doctor’s office to get an injection.  You don’t have to get poked.  But we don’t know yet, how well switching from carfilzomib to Ixazomib or switching from bortezomib or Ixazomib would work. 

So I think for now, until we have that information, I would suggest that if people are on a treatment which is working, they should probably continue with that rather than to switch to something where there may be a bit of an unknown. 

Andrew Schorr:                  

Yeah, again, the old phrase is if it’s not broken, don’t fix it.  

Dr. Orlowski:     

Exactly.

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you.

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