fbpx
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.

Taking Your Meds – The Challenges of Oral Drug Compliance in Cancer Care

The Journal of Oncology Pharmacy Practice published a research paper recently that was quite an eye opener about how well patients with a new diagnosis of a hematological cancer comply with their oral drug regimens. Refills of all oral drugs (oncolytics and non-oncolytics) were tracked for a large number of patients over a period of [...]

Read More

Infections, Facemasks and Multiple Myeloma

Living with Myeloma also means living with an increased risk of infections, especially upper respiratory infections and those infections are tougher to control and treat as our immune systems are weakened by prolonged treatment with our myeloma meds and stem cell transplants. Out of control respiratory infections are a leading cause of death of multiple [...]

Read More

Something New to Learn in Multiple Myeloma: Invariant Natural Killer T-Cells (iNKT)

A team from UCLA Life Sciences recently published exciting research with engineered natural killer T-cells that could provide long lasting immunity against cancer through the use of invariant Natural Killer T-cells (iNKT’s). iNKT’s have been labeled as the ‘special forces’ of the immune system. Scientists have shown in the past that iNKT’s can target many [...]

Read More

Myeloma Dental Care and Patients on Bisphosphonate Therapy

It is a well-established fact that multiple myeloma patients are at an increased risk for negative outcomes following the onset of infection and that includes dental infections. That, by itself, should be more than enough reason by itself to make doubly sure that we practice good dental/oral health and that we remain on a ‘first [...]

Read More

New Strategies to Improve CAR-T Therapies for Multiple Myeloma

A short but very interesting paper has just been published in the journal Blood Advances that provides insights as to why some multiple myeloma patients have better outcomes than others when treated with anti-BCMA CAR-T. The authors start the paper with a bang: ‘Chimeric antigen receptor (CAR) T cells are a promising, emerging therapy for [...]

Read More

Cannabis and Cancer Immunotherapy: Important Notes for Myeloma Patients

Much is being written these days about the use of cannabis in cancer treatment. There is already some acknowledgment of the palliative effects of cannabis for cancer patients, especially as an agent that may alleviate chemo induced nausea. There is also some very early/emerging research on the potential curative effect of cannabis on certain cancers. [...]

Read More

Interesting Early Research in Multiple Myeloma

We prefer to focus on developments in late state research as those give us something to look forward to in terms of treatment alternatives that may become available to us in the ‘near term’. That doesn’t mean, however, that we should ignore results from early research. Novel treatments and treatment combos are already extending the [...]

Read More

CLR 131 : Progress on a New Approach to Treat Relapsed/Refractory Multiple Myeloma

The company Cellectar Biosciences announced that it has received USFDA’s fast track designation for its research candidate CLR 131 in fourth line, or later, relapse/refractory multiple myeloma. CLR 131 presents a somewhat novel approach to treat our disease. This follows Orphan Drug Designation for the same indication in 2014, followed last year by both Orphan [...]

Read More

Melflufen puts Melphalan in the News Again

Those of us who went through the stem cell transplant process are, undoubtedly, familiar with melphalan. This is the drug that is typically used in the conditioning regimen [the step to ‘kill’ the myeloma cells] prior to transplant. We recently posted another article about the potential benefit of combining melphalan with busulfan in ‘conditioning’. A [...]

Read More

Lenalidomide Reduces Risk of Progression in High Risk Smoldering Myeloma

An interesting head-on comparison study was presented at ASCO a few days ago in patients with high risk SMM. The study compared “observation” (somewhat akin to ‘do nothing until things get worse’) to starting to treat patients with lenalidomide (Revlimid) early on. Lenalidomide is a drug that is well known to the average multiple myeloma [...]

Read More

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 [...]

Read More

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 [...]

Read More

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. [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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

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 protein, that [...]

Read More

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 reports on the results of a small study where Kymriah was used [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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, [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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

A paper was just published in the 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 specific interest to [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More

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 [...]

Read More