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Results from a small Phase 2 study conducted in Italy demon­strate that se­quen­tial treatment with novel agents and au­tol­o­gous stem cell trans­plan­ta­tion with intermediate-dose melphalan is a safe and ef­fec­tive treat­ment for older, newly diagnosed myeloma patients.

“This is the first study with a sequential approach of Velcade in­duc­tion, autol­o­gous stem cell trans­plan­ta­tion, and Revlimid main­te­nance,” said the study’s lead investigator, Dr. Antonio Palumbo of the University of Torino in Italy.

The regimen was safest in patients under the age 70; patients aged 70 years and older ex­peri­enced more treatment-related side effects …

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Stem Cell Mobilization With Cyclophosphamide And G-CSF Is More Effective And Less Expensive Than Mozobil And G-CSF – Findings from a recent study show that cyclo­phos­phamide (Cytoxan) plus granulocyte colony-stimulating factor (G-CSF) is more ef­fec­tive than Mozobil (plerixafor) plus G-CSF as a stem cell mobilization ther­apy for mul­ti­ple myeloma patients. Both Mozobil and cyclo­phos­phamide in­crease the number of stem cells that can be harvested during collection. Patients in the recent study who re­ceived the cyclo­phos­pha­mide-G-CSF com­bi­na­tion collected sig­nif­i­cantly more stem cells than patients who re­ceived Mozobil plus G-CSF (16.6 × 10⁶ cells/kg versus 11.6 × 10⁶ cells/kg). In addi­tion, the in­ves­ti­ga­tors found that the total cost of stem cell mobilization was less with cyclo­phos­pha­mide plus G-CSF than with Mozobil plus G-CSF. However, cyclo­phos­phamide plus G-CSF was asso­ci­ated with sig­nif­i­cantly higher rates of side effects, antibiotic use, and hospi­tal­iza­tion. For more in­for­ma­tion, please see the study in Bone Marrow Transplantation (abstract).

Psychosocial Support May Be Appropriate For Newly Diagnosed Myeloma Patients - Results from a German study in­di­cate that about half of newly diag­nosed mul­ti­ple myeloma patients desire psychosocial sup­port soon after their diag­nosis. Psychosocial sup­port in­cludes services in­tended to help a myeloma patient with the psychological, emotional, social, and practical effects of their diag­nosis and treat­ment.  Of the 114 myeloma patients in­cluded in the study, 51 per­cent desired psychosocial sup­port, with depressed and younger patients having the greatest interest. Specifically, patients were most interested in relaxation techniques (21 per­cent), psychological counseling (20 per­cent), and peer sup­port groups (18 per­cent). At the time of diag­nosis, 24 per­cent of patients reported signs of depression and 8 per­cent reported signs of anxiety. Based on their findings, the re­searchers rec­om­mend that a variety of dif­fer­en­t types of psychosocial sup­port be offered to myeloma patients at the time of diag­nosis. For more in­for­ma­tion, please refer to the study in the journal Psycho-Oncology (abstract).

Preclinical Study Indicates Melphalan-Flufenamide May Be Effective In Multiple Myeloma – Results from a pre­clin­i­cal study in­di­cate that a new mel­phalan-based treat­ment may be ef­fec­tive for mul­ti­ple myeloma. The treat­ment, known as mel­phalan-flufenamide or J1, is being devel­oped by the Swedish pharma­ceu­tical com­pany Oncopeptides and consists of melphalan (Alkeran) 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. Specifically, the results showed that  melphalan-flufenamide ef­fec­tively killed myeloma cells that were resistant to Velcade (bor­tez­o­mib) and mel­phalan alone. The re­searchers found that even low doses of mel­phalan-flufenamide were ef­fec­tive and should be safer than the doses of mel­phalan cur­rent used to treat myeloma. For more in­for­ma­tion, please refer to the study in Clinical Cancer Research (abstract).

Clinical Trial To Study WT1 Vaccine In Multiple Myeloma Patients – The Memorial Sloan-Kettering Cancer Center has launched a pilot trial to study the Wilms Tumor 1 (WT1) vaccine in mul­ti­ple myeloma patients who just re­ceived a stem cell trans­plant. WT1 is a pro­tein that is often present in myeloma cells. The goal of the study is to de­ter­mine whether the vaccine activates the patient’s immune sys­tem against myeloma cells with WT1. Eligible patients must be at least 18 years old, have WT1-positive myeloma, and be eli­gible to undergo an au­tol­o­gous stem cell trans­plant. For more in­for­ma­tion on the trial, please see the clinical trial description.

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Entinostat And Treanda Enhance Each Other’s Efficacy Against Myeloma Cells – Results from a recent preclinical study show that Treanda (bendamustine) and the investigational drug entinostat (SNDX-275) enhance each other’s efficacy against multiple myeloma cells.  The two drugs, when given together, were more effective than expected based on the efficacy of either drug alone. Entinostat is an oral treatment that belongs to a family of anti-cancer drugs called HDAC inhibitors. Other HDAC inhibitors under investigation for multiple myeloma include Zolinza (vorinostat) and panobinostat.  Entinostat is currently being studied in clinical trials for patients with leukemia and breast cancer.  A Phase 1 study of Entinostat in myeloma patients and other blood cancer patients was recently completed, but the results have not been published yet. Treanda is approved in the United States as a treatment for chronic lymphocytic leukemia and certain lymphomas, and it is being investigated as a treatment for myeloma. It belongs to a class of drugs known as alkylating agents, which also includes melphalan (Alkeran) and cyclophosphamide (Cytoxan). These drugs damage the DNA of cancer cells, triggering their death. For more information, please refer to the study in Cancer Letters (abstract).

Low Levels Of Adiponectin May Be Associated With A Higher Risk Of Developing Myeloma – Findings from a prospective study show that low levels of the protein adiponectin may be associated with a higher risk of developing multiple myeloma. Adiponectin regulates glucose levels in the blood and is found at lower levels in people who have type-2 diabetes or who are obese. The investigators of the current study compared the levels of different proteins known as adipokines in 174 myeloma patients and 348 healthy individuals. They found that myeloma patients had lower levels of adiponectin than healthy individuals. Based on their findings, the researchers recommend further study of adiponectin as a possible therapeutic target for myeloma. For more information, please see the study in Cancer Epidemiology, Biomarkers, and Prevention (abstract).

Etoposide, Thiotepa, and Melphalan May Be More Effective Than Melphalan Alone – Results from a recent Israeli study show that treatment with etoposide (VP-16), thiotepa, and melphalan may be more effective than melphalan alone prior to stem cell transplantation. In particular, patients who received the three-drug combination had a longer time to progression (44 months versus 17 months) and longer overall survival (not yet reached after a median of 108 months follow-up versus 59 months) than those who received melphalan alone. However, the researchers said that based on the small number of patients included in the study, the three-drug combination appeared to be slightly more toxic than melphalan alone. The investigators still believe that the three-drug combination can be effective in certain myeloma patients receiving a stem cell transplant. Etoposide is a chemotherapy drug used as a treatment for lung and testicular cancer. Previous studies have shown that etoposide is highly effective in mobilizing stem cells. Thiotepa, like melphalan, is an alkylating agent that damages the DNA of cancer cells. For more information, please refer to the study in the journal Leukemia and Lymphoma (abstract).

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Painkiller May Mobilize Stem Cells – Results of a recent U.S.-based study indicate that the painkiller meloxicam (Mobic) mobilizes stem cells from the bone marrow to the circulating blood so that they can be collected for stem cell transplantation. Like ibuprofen and aspirin, meloxicam is a nonsteroidal anti-inflammatory drug that is being used for the treatment of pain, fever, and inflammation. However, it causes fewer gastro­intestinal side effects than ibuprofen and aspirin. The researchers found that meloxicam inhibited prostaglandin E2, a hormone-like substance that participates in a wide range of body functions, which in turn caused modest levels of stem cells, as the study investigators described it, to leave the bone marrow. For more information, please see the study in the journal Nature (abstract).

Spectrum Licenses New Formulation Of Melphalan From Ligand – Spectrum Pharmaceuticals announced earlier this month that they have licensed a new intravenous formulation of melphalan (Alkeran) from Ligand Pharmaceuticals. The new formulation does not include propylene glycol, which is used in the current intravenous formulation of melphalan and has been reported to cause kidney- and heart-related side effects.  If the new formulation proves to be safer, it may allow physicians to administer melphalan at higher doses. The new formulation has received orphan drug designation from the U.S. Food and Drug Administration (FDA). The FDA’s orphan drug program encourages the development of treatments for rare diseases. Companies developing an orphan-designated drug receive targeted tax incentives and fee reductions.  In addition, if an orphan-designated drug is eventually approved by the FDA, it is given extended protection against certain kinds of competition.  Spectrum expects to file a new drug application with the FDA in the first half of 2014. For more information, please see the Spectrum Pharmaceuticals press release.

Good Oral And Dental Health May Help Prevent Osteonecrosis Of The Jaw In Myeloma Patients – Results of a small German study indicate that good oral and dental health may help prevent the development of osteonecrosis of the jaw in multiple myeloma patients. Osteonecrosis of the jaw is a condition that is associated with a loss of blood supply to the jaw, causing the jawbone tissue to die. It can occur in multiple myeloma patients during bisphosphonate treatment. The German researchers found that patients with good oral and dental health had a significantly longer time without osteonecrosis of the jaw after the start of bisphosphonate treatment (40 months) than patients with poor oral and dental health (14 months). However, the researchers also found that these factors did not play a role in the course of the ostenecrosis once the disease occurred. For more information, please see the study in the journal Oral and Maxillofacial Surgery (abstract).

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Results of a recent small Australian study suggest that multiple myeloma patients who relapse within 12 months of their first transplant may benefit from a second transplant with melphalan plus Velcade as the intensive therapy immediately prior to their second transplant.

Based on these findings, the investigators propose that this regimen be further explored in the context of back-to-back stem cell transplants in patients who are at risk for an early relapse.

The study investigators note, however, that their study was small and retrospective in nature, and that a follow-up study with …

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Results from an Italian Phase 1/2 trial show that a combination therapy consisting of lower doses of Velcade, melphalan, and prednisone may be an effective and safe salvage therapy for older multiple myeloma patients.

Over half of the patients in the trial responded to the treatment, and according to the study investigators, the treatment was well tolerated, making it a viable treatment option for older myeloma patients.

In Europe, the combination treatment of Velcade (bortezomib), melphalan (Alkeran), and prednisone – commonly referred to as VMP – is often given as initial therapy to …

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Results from a recent Spanish study suggest that treatment with a combination of intravenous busulfan and melphalan is as effective as melphalan alone in preparing patients with multiple myeloma for stem cell transplantation.

Given that the busulfan (Busulfex)-melphalan (Alkeran) regimen uses a lower dose of melphalan (140 mg/m²) than the melphalan-only regimen (200 mg/m²), these findings may benefit patients who are unable to tolerate high doses of melphalan.

A previous study found that an oral busulfan-melphalan combination might be more effective but not as safe as melphalan alone in preparing …