Opinion»

In September 2015, after three months of induction with Revlimid (lena­lidomide), Velcade (bortezomib), and dexamethasone (Decadron), my IgA heavy chain M-spike had fallen from 6.5 g/dL (65 g/L) to zero. My doctor felt that the time was right to get onto the next phase of treatment – a stem cell transplant.

I remember being apprehensive, but actually quite excited at the same time, as this procedure seemed to be the door to a real chance of re­mission and – with luck – many years of good health …

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Good morning, myeloma world.

We have got quite an eclectic mix of myeloma-related research to report on today, ranging from a couple of lengthy review articles to a short case report.

Speaking of case reports, there are several of them, and we'll start with an unusual one. It's from a group of physicians at a hospital in Milan, Italy. They report on a patient with light chain monoclonal gammopathy who tested positive – incorrectly – on a standard test used to determine if someone regularly drinks a lot of alcohol (abstract). …

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Results from a recent study indicate that collecting more stem cells prior to a myeloma patient’s first transplant may be beneficial for future trans­plants.

Specifically, relapsed patients who received a second transplant with cells that had been collected prior to their first transplant, rather than those collected following the first transplant, had a lower risk of later developing myelodysplastic syndromes (MDS).

MDS is a group of blood disorders marked by ineffective production of blood cells.  MDS often progresses to acute myeloid leukemia, an ag­gres­sive blood cancer in which the body overproduces abnormal …

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Velcade Receives Additional Approvals In Europe – The approved uses of Velcade (bor­tez­o­mib) for mul­ti­ple myeloma patients were recently ex­panded in the Euro­pean Union. These addi­tional approved uses in­clude treat­ment of newly diag­nosed trans­plant-eligible myeloma patients with Velcade plus dexa­meth­a­sone (Decadron) or Velcade plus thalidomide (Thalomid) and dexa­meth­a­sone, as well as retreatment of re­lapsed myeloma patients with Velcade for those who responded to prior Velcade ther­apy.  Previously, Velcade was approved in com­bi­na­tion with melphalan (Alkeran) and prednisone for the treat­ment of newly diag­nosed myeloma patients who are in­eli­gible for stem cell trans­plan­ta­tion, or as a single agent for the treat­ment of re­lapsed myeloma patients with one prior ther­apy who have had a trans­plant or are in­eli­gible for a trans­plant.   For more in­for­ma­tion, please see the August 8 and June 28 Johnson & Johnson press releases about the new ap­­prov­als for newly diag­nosed and re­lapsed myeloma patients.

Pilot Clinical Trial To Test Whether Anti-Depressant Desipramine Assists With Stem Cell Mobilization – Researchers from the Albert Einstein College of Medicine in New York City have launched a clin­i­cal trial that will de­ter­mine how well the antidepressant desipramine (Norpramin, Pertofrane) in com­bi­na­tion with Neupogen (filgrastim), which is a type of granulocyte colony-stimulating factor (G-CSF), works to mobilize stem cells in mul­ti­ple myeloma patients undergoing stem cell trans­plan­ta­tion. A pre­vi­ous study in mice showed that desipramine plus G-CSF mobilized more stem cells than G-CSF alone.  For more in­for­ma­tion about the study or how to en­roll, see the clinical trial description.

Clinical Trial To Study Modified Version Of Melphalan Plus Dexa­meth­a­sone For Re­lapsed / Re­frac­tory Myeloma – A new Phase 1/2 clin­i­cal trial is testing the ef­fi­cacy and safety of a modified version of mel­pha­lan in com­bi­na­tion with dexa­meth­a­sone for re­lapsed and re­frac­tory myeloma patients. The modified version of mel­phalan, known as mel­phalan-flufenamide or melflufen, is being devel­oped by the Swedish pharma­ceu­ti­cal com­pany Oncopeptides and consists of melphalan bound to flufenamide.  The drug only be­comes active once it enters a cell and mel­phalan is released from flufenamide.  Cancer cells more efficiently ac­ti­vate the drug, in­creas­ing the con­cen­tra­tion of mel­phalan in cancer cells com­pared to healthy cells. The study is sponsored by Oncopeptides and is being conducted in the United States and Europe. For more in­for­ma­tion about the study or how to en­roll, see the clinical trial description and related Oncopeptides press release.

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Hybrid Drugs Based On Thalidomide And Curcumin May Be A Future Treat­ment Option For Myeloma Patients – Results from a recent preclinical study indicate that hybrid molecules combining chemical structures from thal­ido­mide (Thalomid) and curcumin may be potential treatments for multiple myeloma. Specifically, the investigators found that two particular hybrid mole­cules were effective in killing myeloma cells and were safer than either drug alone. Cur­cu­min is the major active compound in turmeric, a popular Indian spice. Several early-stage studies have investigated curcumin's potential as a myeloma treat­ment (see related Beacon news articles). Ac­cord­ing to the re­search­ers, hybrid drug therapy, which involves combining elements from two or more drugs into one molecule, is a promising treatment option for myeloma because it may be be safer and associated with a reduced risk of developing drug resistance. For more information, please refer to the study in the journal Organic and Bimolecular Chemistry (abstract).

Tandem Autologous Stem Cell Transplants May Not Cause Serious Heart Problems – Results from a small, retrospective Slovenian study suggest that two back-to-back, or tandem, autologous stem cell trans­plants (using the patient’s own cells) may not cause serious heart problems in the long-term. The study in­cluded 12 patients, each of whom received cyclo­phos­pha­mide (Cytoxan) for stem cell mobiliza­tion, and then high-dose chemotherapy with melphalan (Alkeran) prior to each transplant.  None of the patients de­vel­oped critical heart issues six years after their tandem transplant.  However, the re­search­ers did detect some signs of heart damage in the more detailed tests they carried out.  Thus, the authors recommend long-term follow-up studies with tandem transplant patients, in part because of the increasing life expectancy of myeloma patients. For more information, please see the study in journal Radiology and Oncology (full-text).

Methotrexate-Cytarabine Combination May Be Useful For Stem Cell Remobilization – Results from a small study conducted in South Korea indicate that a combination of high-dose methotrexate and cytarabine (Cyto­sar-U) plus granulocyte colony-stimulating factor (G-CSF) may be a useful alternative for stem cell mobili­za­tion.  Cytarabine is an older chemo­thera­py drug which has been used in the treatment of certain leukemias and lymphomas.  Methotrexate also is an older drug, which has been used in high doses as a chemo­thera­py agent, and in low doses to treat various auto­immune dis­orders, including rheuma­toid arthritis.  The Ko­re­an study included eight patients who had previously failed to mobilize sufficient stem cells using regimens including G-CSF and conventional chemo­therapy agents.  Of those eight patients, all but one were able to mobilize a sufficient number of stem cells using the methotrexate-cytarabine-G-CSF combination. The re­search­ers point out that larger studies are necessary to confirm their findings. For more information, please refer to the study in the journal Transfusion (abstract).

Donated, Virus-Specific White Blood Cells Effective For Severe Viral Infections After Donor Trans­plan­ta­tion – Results of a recent study show that donated t-cells, a type of white blood cell, can be used to treat severe viral infections in patients who have undergone allogeneic (donor) stem cell trans­plan­ta­tion.  During the study, virus-specific t-cells were collected from individuals who were immune to certain viral infections. The do­nated t-cells were then used to treat a total of 50 patients who had undergone a donor stem cell trans­plant and then developed a severe viral in­fec­tion.  In 74 percent of the cases, the donated t-cell treat­ment led to either a partial or complete elimination of the viral infection.  According to the researchers, the treatment was well tolerated; there were no infusion-related side effects, and only 4 percent of the patients developed graft-versus-host disease after the t-cell infusions.  Graft-versus-host disease is a com­pli­ca­tion that arises when donor cells identify the recipient cells as foreign and attack them. For more information, please the study in the journal Blood (full text).

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Daratumumab Receives Break­through Therapy Desig­na­tion For Multiple Myeloma – The U.S. Food and Drug Admin­istra­tion (FDA) last week granted breakthrough ther­apy desig­na­tion to the inves­ti­ga­tional drug daratumumab. The breakthrough ther­apy desig­na­tion is a new desig­na­tion, signed into law in 2012.  It is designed to accelerate the devel­op­ment and review process for drugs in­tended to treat serious or life-threatening illnesses. Dara­tu­mu­mab is being devel­oped by the Danish bio­technology com­pany Genmab together with Janssen Biotech, a Johnson & Johnson (NYSE: JNJ) sub­sid­i­ary. It is a mono­clonal anti­body, like elotuzumab and siltuximab, that signals the immune sys­tem to kill myeloma cells. Results from a Phase 1/2 clin­i­cal trial indicated that dara­tu­mu­mab is effec­tive in heavily pre­treated myeloma patients (see related Beacon news). For more in­for­ma­tion, please see the Genmab press release.

Statins May Aid Stem Cell Collection In Multiple Myeloma – Results from a recent retro­spec­tive­ study indicate that statins may have a pos­i­tive impact on stem cell collection in multiple myeloma patients. Specifically, the researchers found that the success rate for sufficient stem cell collection was higher in patients who received statins during stem cell collection (85 per­cent), com­pared to patients who did not receive statins (64 per­cent). All patients received granulocyte colony-stimulating factor (G-CSF) as a stem cell mobilizing agent. The researchers point out that larger studies are nec­es­sary to con­firm their findings. Statins are drugs that lower cholesterol levels by inhibiting cholesterol pro­duc­tion in the liver. Atorvastatin (Lipitor) is the most common statin admin­istered to patients with heart disease. A pre­vi­ous study showed that statins reduce a myeloma patient’s chance of devel­op­ing the com­pli­ca­tion graft-versus-host disease after undergoing a donor stem cell trans­plant (see related Beacon news). For more in­for­ma­tion, please refer to the study in the journal Clinical Translational Oncology (abstract).

Study Finds Bisphosphonates May Not Decrease Kidney Function In Myeloma Patients Undergoing Stem Cell Transplantation – Findings from a retro­spec­tive­ study show that the bis­phos­pho­nates Boniva (ibandronate), Aredia (pamidronate), and Zometa (zoledronic acid) may not sig­nif­i­cantly de­crease kidney function in multiple myeloma patients undergoing stem cell trans­plan­ta­tion. The researchers also found that the impact of each of the three bis­phos­pho­nates on kidney function were similar.  Specifically, 33 per­cent of patients who received Boniva, 44 per­cent who received Aredia, and 21 per­cent who received Zometa ex­peri­enced a de­crease in creatinine clearance of at least 25 per­cent over the course of bis­phos­pho­nate ther­apy.  The researchers conclude that bis­phos­pho­nate ther­apy for up to three years appears to be safe on kidneys. Bisphosphonates are prescribed in multiple myeloma to slow down and prevent bone destruction. Previous studies have found that bis­phos­pho­nates may cause kidney damage. For more in­for­ma­tion, please see the study in the International Journal of Hematology (abstract).

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[ by Virginia Li | May 3, 2013 7:33 pm | One Comment ]

A recent retrospective study finds that initial treatment with Revlimid may not prevent myeloma patients from collecting enough stem cells for transplantation.

Many of the study's results confirm the findings of previous research, which has shown that Revlimid (lenalidomide) reduces a patient's ability to mobilize stem cells for stem cell collection (see related Beacon news).

However, only 2 percent of the patients in the new study were unable to mobilize enough stem cells for at least a single transplant, and this low overall rate of mobilization failure was the same in patients who …