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A new retrospective study provides insight into the benefit the new mye­lo­ma drugs Kyprolis and Pomalyst may provide to patients who are re­sis­tant to, or cannot tolerate, both Velcade and Revlimid.

The study's results highlight how challenging it can be to find an effective treat­ment for patients who are “dual refractory” (resistant to both Velcade and Rev­li­mid).

Patients in the study who received either Kyprolis (car­filz­o­mib) or Poma­lyst (poma­lido­mide, Imnovid) after becoming dual refractory had longer over­all survival than those who were not treated with the new drugs.

The …

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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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Results from a small Phase 2 study conducted throughout Japan sug­gest that a com­bi­na­tion of Velcade, doxorubicin, and intermediate-dose dexa­meth­a­sone is effective in patients with re­lapsed or refractory multiple myeloma.

Most patients (89 per­cent) responded to treat­ment, with a third of them achieving a com­plete or near com­plete response.  In addi­tion, the medi­an pro­gres­sion-free survival was 12.1 months.

According to the Japanese researchers, the findings from this study are com­par­able to those from pre­vi­ous studies that examined the effective­ness of the Velcade (bor­tez­o­mib), doxorubicin (Adriamycin), and

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Results from a recent small Phase 3 clinical trial show that the use of Velcade in preparation for donor stem cell transplantation as well as its use soon after transplantation and as maintenance therapy may be effective in high-risk multiple myeloma patients.

The results also indicate that the use of Velcade (bortezomib) soon after donor trans­­plan­­ta­­tion reduces the risk of developing a life-threatening donor trans­plant-related complication known as graft-versus-host disease.

The researchers note that, similar to other donor transplant protocols, the relapse rate was high. Thus, they recommend study of other novel …

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Revlimid Plus Dexamethasone Extends Progression-Free Survival In Newly Diagnosed Multiple Myeloma Patients – Results of a large international Phase 3 trial show that Revlimid (lenalidomide) plus dexamethasone (Decadron) ex­tends progression-free survival in newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplantation, compared to treat­ment with melphalan (Alkeran), prednisone, and thalidomide (Thalomid). Based on these findings, Celgene, the manufacturer of Revlimid, will start the pro­cess of applying for approval of Revlimid as frontline treat­ment in the United States, Europe, and other countries. Although Celgene is widely used in the U.S. for the treatment of newly diagnosed myeloma patients, it is not officially approved for that use in the U.S. or any other country.  For more information, please see the related press release from Celgene.

Order Of Velcade And Revlimid Treatment May Not Matter In Treating Myeloma – Results from a recent retrospective study indicate that multiple myeloma patients benefit equally whether they are treated with Velcade (bortezomib) before Revlimid, or vice versa. However, patients with kidney disease tend to benefit from earlier use of Velcade-based therapies. Both Revlimid- and Velcade-based therapies have become common treatment options for myeloma patients. The investigators of this study were interested in de­ter­min­ing whether one drug should be given before the other. In their analysis, which was based on data for 208 myeloma patients treated between 2003 and 20089, the authors adjusted for a number of potential biases, such as patient age, number of previous therapies, and whether or not a patient had received a stem cell transplant.  The researchers found no significant difference in median overall survival between patients who received Revlimid first versus those who received Velcade first. For more information, please refer to the study in the journal Leukemia Research (abstract).

Unrelated Donor Stem Cell Transplant May Be An Under-Utilized Treatment Option For Myeloma – Find­ings from a retrospective study suggest that donor stem cell transplants using cells from unrelated donors may be underutilized for myeloma patients, particularly older myeloma patients. Specifically, the researchers found that only 11 percent of the myeloma patients they estimated to be eligible for an unrelated donor trans­plant actually underwent the procedure. Reasons for not undergoing a transplant included not being referred to a transplant center, worsening health condition of the patient, a prolonged search for a suitable donor, and financial issues. Donor (allogeneic) stem cell transplants involve infusing a patient with donor stem cells after high-dose chemotherapy. While the procedure has the potential to cure myeloma, it also is often accompanied by serious complications, including graft-versus-host-disease (GVHD), in which donor im­mune system cells recognize the patient's cells as foreign and attack them. For more information, please re­fer to the study in the journal Biology of Blood and Marrow Transplantation (ab­stract).

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Researchers at the Medical College of Wisconsin recently found that mul­ti­ple myeloma patients are at an increased risk of engraftment syndrome following stem cell transplantation, compared to patients with lym­pho­ma. Engraftment syndrome is a complication that can occur soon after stem cell transplantation.

Within the myeloma population, the risk of engraftment syndrome was in­creased in patients who are over 60 years of age, have been treated with the novel agents Revlimid (lenalidomide) and/or Velcade (bortezo­mib), or have not been treated with cyclo­phos­phamide (Cytoxan).

“The most important finding is the increased …