By Paul Kleutghen | Posted - Jul 9th, 2020

 

 

 

 

High Risk Myeloma and the Benefit of Tandem Transplants with Long-Term Revlimid Maintenance

This is an interesting article to write as I definitely qualify as being someone who lives with ‘high risk’ myeloma (mine is primary Plasma Cell Leukemia – supposedly the ugliest of the myeloma variants). 

There have been debates in the MM community as to the best course of action : single or tandem (two back-to-back auto stem cell transplants) and different courses of post-transplant treatment. We finally have the benefit of long-term follow-up data that provide us with factual outcomes that make this debate more productive. These facts come from long-term data gathered from 758 newly diagnosed myeloma patients who were divided into the three equal groups, each with a different treatment program. The study was done at the University of Wisconsin and Dr. Hari presented the results at the most recent ASCO meeting.

The different groups were randomly assigned to one of three courses of treatment :

  • Tandem SCT followed by 3 years of Revlimid maintenance.
  • A single SCT, consolidation with Revlimid/Velcade/dexamethasone (RVd), followed by 3 years of Revlimid maintenance.
  • A single auto SCT and also followed by 3 years of Revlimid maintenance.

The original study intended to stop after the 3 years of Revlimid maintenance, but this study was amended to allow continued Revlimid maintenance for those patients who continued to be Progression Free after the initial 3-year period.

Key results can be summarized as follows :

  • Overall survival was similar between the 3 groups.
  • The 6-year PFS was significantly higher for patients who underwent tandem HSCT, at 49.4%, compared with 39.7% for  those who were treated with a single SCT followed by RVd consolidation, and 38.6% for those who received a single auto SCT.
  • High risk patients had a significantly better PFS after tandem SCT compared to standard risk patients who received an auto SCT.
  • Patients who remained on Revlimid maintenance after 3 years had a significantly better PFS than those who stopped Revlimid after 3 years. This benefit is more pronounced in standard risk patients where the 5-year PFS was 86 %, whereas patients who stopped Revlimid maintenance after 3 years had a 5-year PFS of 86 %.
  • High risk patients who continued Revlimid maintenance had a five-year PFS of 86 % compared to the same period PFS of 67 % for those who stopped Revlimid maintenance. The problem here, however, is that there were too few high-risk patients for this difference to be statistically significant. That is, unfortunately, just the way the cookie crumbles in the world of mathematical statistics.

The key conclusions of this study are:

  • The tandem auto SCT may still be relevant in the treatment of high-risk MM.
  • It is not recommended to stop Revlimid after 3 years maintenance if you, the patient, is doing well and have not yet relapsed or become refractory to Revlimid. I am sensitive that Revlimid maintenance is not a cheap proposition, especially for patients who are living off Social Security. That $ 865 co-pay, every 4 weeks (or so) takes a big bite out of that Social Security check. Still, if you are doing well, is it worth it to set aside $ 30/day to enjoy your Family and friends ? 

I started this post on a personal note and let me finish it with a personal note. Six years ago, I was faced with the choice of either going the auto-allo SCT route or the tandem SCT route. Professor Dr. Gasparetto at Duke laid out the differences of the risks of both to me in very plain terms. Quality of life, as opposed to length of life, were more important to my family and myself. With that in mind, Dr. Gasparetto recommended the tandem auto, followed by consolidation with high dose Revlimid/Velcade and then continued maintenance with lower dose Revlimid/Velcade. I have been doing this for six years now, still progression free, and have been able to see grandson #1 grow up to a super 8-year old, have seen grandson #2 come into the world 8 months ago and be able enjoy his smile that will melt the heart of the toughest person out there. All of this with my sincerest thanks to the team of the Duke Center for Hematological Malignancies and Cell Therapy, to Cristina Gasparetto, MD, but, most of all to my wife, Vicki, who traveled this road together with me. As Robert Frost wrote, years ago (with one small modification):

“I shall be telling this with a sigh

Somewhere ages and ages hence,

Two road diverged in a wood, and we –

We took the one less travelled by,

And that has made all the difference.”

 

 

 
Paul Kleutghen
About the Author

Paul Kleutghen - I am a patient diagnosed in 2014 with primary plasma cell leukemia (pPCL), a rare and aggressive variant of multiple myeloma and have been very fortunate to find treatment at the division of Cellular Therapy at the Duke University Cancer Institute. My wife, Vicki, and I have two adult children and a grandson who is the ‘light of my life’. Successful treatment has allowed Vicki and I to do what we love best : traveling the world, albeit it with some extra precautions to keep infections away. My career in the pharmaceutical industry has given me insights that I am currently putting to use as an advocate to lower drug pricing, especially prices for anti-cancer drugs and, very specifically, CAR-T therapies, with recent contributions posted by Health affairs, the Institute for Clinical and Economic Review and the Centers for Medicare and Medicaid Services.

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