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Paul Kleutghen

About 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.

Identifying Patient Response to CAR T: What Other Blood Cancers Can Teach Us

This is not quite a multiple myeloma article, but still good to know … I am quite certain that over the past week many of us have seen the blizzard of press mentions of the early results of the investigational anti-BCMA CAR-T product bb2121 (Bluebird-Celgene) in MM patients published in the New England Journal of [...]

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Busulfan Plus Melphalan: A Promising Combination For Auto-Stem Cell Transplant in Multiple Myeloma

Those of us who have had an autologous stem cell transplant most likely had a regimen using melphalan as the myelo-ablating agent. For those who are scheduled for auto-SCT: you may be interested in a short, but very interesting paper that was just published in The Lancet Haematology. This paper reports on a trial that [...]

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Potential Future Product to Lower the Cost of Multiple Myeloma Treatment

It is safe to speculate that the average myeloma patient is attuned to the high cost of their treatment. We have seen results of recent studies, as well as some FDA approvals, of triplet and quadruplet therapies where the annual cost of treatment adds up to amounts in the $500,000 to +$750,000 per year range. [...]

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VERY Early Detection of Multiple Myeloma

A very recent article in the journal Nature Medicine presents results from research done at the Weizman Institute of Science in Israel. The ‘easier’ summary of this article can be found here. As multiple myeloma patients, we are constantly reminded that our disease is heterogeneous. In other words, we present ourselves differently, with different symptoms [...]

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A New Target in the Fight Against Multiple Myeloma – IFNAR1

Quite a bit has already been posted on the Myeloma Crowd site about the CAR-T Cells. Up until now, T-cells have been discussed without mentioning that there are actually three different kinds of T-cells: Regulatory T-cells (Treg) Helper T-cells (Th - also sometimes called effector T-cells) Cytotoxic T-cells In general, T-cells are a type [...]

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What is the Significance of ‘Breakthrough Therapy’ Designation in Multiple Myeloma?

Quite frequently, we read that the US Food and Drug Administration (USFDA) has designated drugs under development with ‘Breakthrough’ status. The ‘Breakthrough Therapy Program’ was established by the US Congress in 2012 to expedite the review and development of promising new therapies. During the period from mid-2012 and the end of 2017, the FDA granted [...]

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Clinical Trial: New Monoclonal Antibody for Relapsed Multiple Myeloma (Lintuzumab + Actinium-225)

Actinium Pharmaceuticals is currently recruiting patients with Relapsed/Refractory (RR) multiple myeloma for a Phase I clinical trial to study the safety and efficacy of the drug lintuzumab in combination with actinium-225. Lintuzumab is a humanized monoclonal antibody that has was originally developed for the treatment of Acute Myeloid Leukemia (AML). Lintuzumab targets the CD33 cell surface [...]

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Small Study Results of Autologous Stem Cell Transplant and Kymriah to Treat Multiple Myeloma

Kymriah (marketed by Novartis), the first CAR-T treatment approved in the US (for Pediatric Acute Lymphocytic Leukemia) has now also been approved for the treatment of Diffuse Large B Cell Lymphoma (DLBCL). An article published in the most recent issue of the Journal of Clinical Investigation reports on the results of a small study [...]

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Blood Biopsies vs Bone Marrow Biopsies – The Good News For The Week …

… is a study that was published in the journal Nature Communications by a team from the Dana Farber Cancer Institute and the Broad Institute, a collaborative research effort between MIT and Harvard. This report summarizes the outcomes of a study that shows “that two ways to measure multiple myeloma DNA in blood samples [...]

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Antibody-Drug Conjugates and Multiple Myeloma

The short title for this post may, hopefully, pack quite a punch against multiple myeloma. ADCs, shorthand for antibody-drug conjugates, are an important class of biopharmaceuticals that work very differently compared to chemotherapy. Whereas chemo attacks both malignant and healthy cells, ADCs are intended to only kill the cancerous cells and spare the surrounding [...]

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First Results Published of P-BCMA-101 CAR-T in Relapsed/Refractory Multiple Myeloma

Poseida Therapeutics presented data from the Phase I (lowest dose cohort) of their novel CAR-T product, P-BCMA-101, at last week’s annual meeting of the American Association for Cancer Research (AACR). The presentation focused on the results achieved in the first step of their dose escalation study (NCT03288493)  in patients with relapsed/refractory multiple myeloma. The [...]

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A Way to Improve the Impact of Daratumumab

Daratumomab (Darzalex) and its use in combination with other drugs is becoming a new standard of care in the treatment of multiple myeloma. 'DARZALEX® is a monoclonal antibody that works in several ways. One way this monoclonal antibody works is by attaching itself to multiple myeloma cells in your body and directly killing them, [...]

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40 Genes that Can be Disrupted in Early Stages of Multiple Myeloma

The most recent issue of the journal Leukemia summarizes the results of a study completed by researchers at the Institute of Cancer Research in London. The research team mapped and examined whole genome sequencing data from 765 multiple myeloma patients. The authors start the article with a forceful statement : “Multiple myeloma (MM) is a [...]

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What are the NCCN Guidelines for Multiple Myeloma?

NCCN is a ‘must know’ acronym. It stands for the National Comprehensive Cancer Network, a non-profit alliance of 27 leading cancer centers ‘devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical [...]

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Clinical Trial: Seattle Genetics’ SGN-CD48A Phase I Study for Patients with Relapsed/Refractory Myeloma

Seattle Genetics has just announced that the first patient has been dosed in a Phase I study for their new drug SGN-CD48A for patients with relapsed or refractory multiple myeloma. The Company’s antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. SGN-CD48A is a new drug [...]

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Experts Weigh In On the Use of Liquid Biopsies

We have all been looking forward to the use of liquid biopsies so we can say goodbye (or good riddance?) to the discomfort of bone marrow biopsies. It seems that the goodbye moment is not quite there yet. The American Society of Clinical Oncology (ASCO), together with the College of American Pathology (CAP),  issued a [...]

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Long-Term Follow-Up of MGUS Patients

An interesting article was published in the New England Journal of Medicine last month that reported on the long-term follow-up of MGUS patients. The article Long-Term Follow-up of Monoclonal Gammopathy of Undetermined Significance summarizes the outcomes of 1,384 patients diagnosed with MGUS during the period 1960-1994. The median period that patients’ progress was followed and studied [...]

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Clinical Trial: PT-112 Advances into Clinical Trial for Relapsed or Refractory Myeloma

The company Phosplatin Therapeutics announced a few days ago that it has enrolled the first group of patients in a Phase I/II study of their investigational drug PT-112 to treat relapsed/refractory MM. This study follows the release of preclinical data at ASH 2017. PT-112 is a novel compound that is the first in a new [...]

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New Test for Daratumumab (Darzalex) Patients Helps With M-Protein Accuracy

All myeloma patients are familiar with immunofixation tests (typically abbreviated as IFE, for Immmuno Fixation Electrophoresis), which are tests that looks for the presence of monoclonal cells in the blood (serum). A patient being treated with Darzalex (daratmumab) is infused with monoclonal antibodies and, therefore, the IFE test will show the presence of monoclonals which [...]

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ASH 2017: Will My Stem Cell Transplant Benefit Me?

Many myeloma patients have asked this question to themselves and to their physicians prior to their SCT. We now have an answer to this difficult question and it comes as the result of a very encompassing effort by the Multiple Myeloma Research Foundation (MMRF). Researchers from both US and EU treatment sites pooled very detailed [...]

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ASH 2017: Deep and Durable Responses in Patients with Relapsed/Refractory Multiple Myeloma Treated with Monotherapy GSK2857916

Two weeks ago, Greg Brozeit reported on the Myeloma Crowd site that FDA had granted breakthrough therapy designation to the investigational drug GSK2857916 to the drug firm GlaxoSmithKline (GSK) currently being studied in relapsed/refractory multiple myeloma, as well as in some lymphoma patients. This drug has a unique mechanism of action as it combines an [...]

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Myeloma bb2121 CAR T Therapy Receives FDA Breakthrough Status

Over the past two months we have seen the first two CAR-T products approved in the treatment of hematological diseases (Kymriah for pediatric Acute Lymphoblastic Leukemia and Yescarta for several variants of Non-Hodgkin’s Lymphoma). What about CAR-T for MM ? How much longer do we have to wait for CAR-T to make an impact for [...]

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ASH 2017: Quick ‘Do-It-Yourself’ M-Spike Calculation, the Gamma Gap

There are two similarities between ALL multiple myeloma patients : we are all gluttons for test results, and live by the ‘numbers’, AND we detest having to wait for test results to come in. Some of our treatment centers have responded to the need for patients wanting to discuss test results when they visit with their [...]

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Guidance for use of Pomalidomide in Relapsed/Refractory Myeloma Patients on Dialysis

A paper was just published in the Journal Clinical Pharmacology that may be of interest to those multiple myeloma patients who are taking Pomalyst (pomalidomide) and who are undergoing dialysis treatment. The team of researchers from several US and European myeloma treatment centers report on a pooled study of patients from different clinical studies. Of [...]

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Insight Into Myeloma Proteasome Inhibitor Resistance From a Rare Genetic Disease

BY PAUL KLEUTGHEN Somewhere along our journey in multiple myeloma treatment we will most likely have seen the use of proteasome inhibitors (e.g., Velcade, Kyprolis, Ninlaro) as part of our drug regimen. Unfortunately, some patients will become resistant (refractory) to this very important class of drugs that have become standard in ‘first line’ cocktails used [...]

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Myeloma Decision Making in the Age of CAR T Cell Treatments

The very recent post on the Myeloma Crowd site by Greg Brozeit about a second CAR-T therapy being approved by the FDA in lymphoma provides plenty of food for thought. We can all rejoice in the progress made by CAR-T immunotherapy in the field of hematological malignancies that will, fingers crossed, provide us with yet another [...]

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Repurposing an “old” drug for Multiple Myeloma Treatment

BY PAUL KLEUTGHEN Myeloma patients tend to have two interests in common : novel options to treat their disease and whether something can be done to lower the cost/expense of treatment. The good news is that in the last two years we have seen several new meds come to market and more are expected in [...]

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Gene Discovery May Present a Future Option for Treating High Risk Multiple Myeloma

BY PAUL KLEUTGHEN It is becoming increasingly hard to keep up with the many advances in the treatment of blood cancers. In the case of multiple myeloma, we have seen the advent of several new FDA-approved treatment alternatives and several more are at various stages of clinical effort. It seems that the field of drugs [...]

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An Update on Primary Plasma Cell Leukemia Treatment Options

BY PAUL KLEUTGHEN For the 150, or so, with primary Plasma Cell Leukemia... An interesting article was recently published in the American Journal of Hematology/Oncology for the few of us walking around with primary plasma cell leukemia (pPCL). The article is easy to read and understand and provides insight into current treatment options and what we [...]

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Beginning Myeloma Treatments Impact the Achievement of MRD-negative Goal

BY PAUL KLEUTGHEN The current issue of the Journal of Clinical Oncology reports more interesting research that, again, confirms the importance of achieving minimal residual disease (MRD) negative status in multiple myeloma treatment. This is an important topic that has already been presented earlier on this site. The focal point of the article was to point [...]

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For newly diagnosed MM patients: the importance of lenalidomide maintenance therapy post Transplant

BY PAUL KLEUTGHEN The newly diagnosed MM patient will most likely be overwhelmed not only by his/her diagnosis of a complex disease but also by the prospect of a rigorous treatment program (induction, transplant, consolidation and then maintenance therapy). It is understandable that one may be quite fed-up with “treatment” post consolidation at having to [...]

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Generic Drugs for Multiple Myeloma: Biosimilars

BY PAUL KLEUTGHEN Over the years we have become familiar with generic drugs, approved by FDA, and treated as “the same” as their brand-name cousins by physicians, pharmacists and medical insurers. These substitutable (for the original version) medications come as both oral and injectable/infusible drugs. The exception, however, was for those products that were [...]

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Medicare and the Cost of Multiple Myeloma Drugs

BY PAUL KLEUTGHEN The median age for multiple myeloma patients ranges between 65 and 75, which implies that the majority of myeloma patients are receiving health care benefits under Medicare. The Journal of Clinical Oncology  just published a paper “Rising cancer drug costs counteract financial relief for Medicare recipients”, by Shih, YT et al, June [...]

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Relapse of Multiple Myeloma: What Happens Next?

BY PAUL KLEUTGHEN This is a question that many of us ask ourselves after our auto transplant(s) and as time moves along in our maintenance therapy. Different decision considerations and options are discussed in an easy to understand fashion in an interview with Dr. Rafael Fonseca, MD from the Mayo Clinic in Scottsdale, AZ published [...]

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Myeloma 101: Vaccinations After Myeloma Stem Cell Transplant

BY PAUL KLEUTGHEN Should myeloma patients get re-vaccinated after stem cell transplant? Experts say there are benefits in doing so. An article was published last week coming from this year’s Oncology Nursing Society’s Annual Conference that was titled “Guideline-driven Initiative Improves Pneumococcal Vaccination Rates Among aHSCT Recipients”, authored by Joyce Pagan, May 4, 2017. Of [...]

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An Algorithm to Predict GvHD Post Allogeneic Stem Cell Transplants

BY PAUL KLEUTGHEN Some of us, myeloma patients as well as our caregivers and families, have decided or will be deciding that allo stem cell transplants are the best way to proceed in the long-term treatment of our disease, even in the face of the inherent risks. And those risks are very real. Approximately half [...]

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All you ever wanted to know about Immunomodulators (IMiDs) for Multiple Myeloma

BY PAUL KLEUTGHEN All of us are, most likely, familiar with products such as Thalomid, Revlimid and Pomalyst. Any of those will have been part of our myeloma treatment regimens at some point of time, with Revlimid being the product that is most frequently prescribed. Revlimid and Pomalyst are chemical analogs of Thalomid and this [...]

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Progress in the Development of ‘Liquid Biopsies’ in Multiple Myeloma

BY PAUL KLEUTGHEN Several months ago the Broad Institute (a collaboration between MIT and the Harvard Medical School) reported on the early development of a ‘liquid biopsy’ for multiple myeloma patients – a method to replace bone biopsies with an assay that uses a sample of circulating blood. The Myeloma Crowd, at the time, reported on [...]

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Peripheral Neuropathy and Multiple Myeloma: Not Just Feet and Hands

BY PAUL KLEUTGHEN Just about all myeloma patients are already members of the “Unhappy Feet and Hands” club,  but there is much more to peripheral neuropathy than the standard "How are the hand and feet doing?" our physician asks during routine visits. There is plenty of reading material to be found relating to peripheral [...]

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A Treasure Trove of Myeloma Stem Cell Transplant Data

BY PAUL KLEUTGHEN I have yet to meet a MM-patient who does not want more data and more knowledge at their fingertips, especially at the time of diagnosis and early in the treatment program. There are numerous fabulous websites that do a great job. Let me one more to the list. There is a site [...]

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Skip the Bone Marrow Biopsy, Single Cell Blood Analysis for Myeloma is Coming Soon

BY PAUL KLEUTGHEN Hate myeloma bone marrow biopsies? You're not alone. Soon, the happy day may come where we don't need them. A new article in the journal Science Translational Medicine describes a new testing method where single cells of peripheral blood can be analyzed for a myeloma diagnosis and genetic subtyping without the need [...]

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Hedgehogs, Bortezomib Resistance and Minimal Residual Disease

BY PAUL KLEUTGHEN Many new treatments for multiple myeloma have been introduced over the past decade and have extended the survival of patients, but have failed to cure. One of those therapies is bortezomib – a true breakthrough drug. Some patients, however, develop a resistance to bortezomib at some point during their treatment program. The [...]

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Beta Blockers May Improve Survival Outcomes in Patients with Multiple Myeloma

BY PAUL KLEUTGHEN There has been recent positive press about beneficial effects of “statins” in myeloma treatment that was shared a few weeks ago on the Myeloma Crowd. Now there is similar news about the use of beta blockers. Beta blockers (BB) are a widely prescribed class of drugs used to prevent, treat or improve [...]

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The Power of Poop: One Strange (But Promising) Method to Avoid Acute Graft vs. Host after a Myeloma Allo Transplant

BY PAUL KLEUTGHEN Several studies have been published over the past few years about the beneficial impact of fecal microbiota transplants (FMT’s) in the treatment of chronic Clostridium difficile (C diff) and Crohn’s disease. The Journal Blood recently published an article about a small scale FMT-study done by Kazuhiko Kakihana, MD, PhD, of the hematology [...]

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Living With “Abnormal” Free Light Chain Ratios

BY PAUL KLEUTGHEN In January 2014 I was diagnosed with primary plasma cell leukemia (pPCL), a rare and aggressive variant of multiple myeloma. My treatment at the Duke Adult Bone Marrow Transplant center included a tandem auto stem cell transpant after which I achieved stringent complete response (sCR). I must say, however, that I attribute [...]

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