Good morning, myeloma world.

We all should have seen this coming.

After days and days of having no major myeloma business news to cover here at Myeloma Morning, what hap­pens? Suddenly, there's not just one new myeloma-related business devel­op­ment to discuss. And not just two. But a full three such news items to review.

So let's start with those devel­op­ments, after which we'll take a quick look at a new research article and what's been going on in the Beacon's forum.

Initial Results Of Darzalex MMY3004 Clinical Trial

We …

Silver Spring, MD (Press Release) – On March 30, 2016, the U. S. Food and Drug Admin­istra­tion approved Defitelio (defibrotide sodium, Jazz Pharma­ceu­ticals, Inc.) for the treat­ment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstructive syn­drome, with renal or pul­monary dysfunction fol­low­ing hematopoietic stem-cell trans­plan­ta­tion (HSCT).

The efficacy of defibrotide sodium was in­ves­ti­gated in 528 patients treated on three studies: two prospective clin­i­cal trials and an expanded access study. The patients enrolled had a diag­nosis of hepatic VOD with multi-organ dysfunction after trans­plan­ta­tion. They received …

Earlier this year, an inter­na­tional group of myeloma experts pub­lished a review of ongoing re­search into new myeloma treat­ments.  This review not only described a wide range of po­ten­tial new myeloma treat­ments, but also in­cluded the experts' thoughts on where re­search into new treat­ments should go in the future.

Given the recent new drug appli­ca­tion for car­filz­o­mib and the upcoming annual meeting of the American Society of He­ma­tol­ogy -- which undoubtedly will host dis­cus­sions of many po­ten­tial new myeloma treat­ments -- it seems an appro­pri­ate time to go back to the experts' review from …

Description:
Defibrotide is an anticoagulant (a drug that prevents blood clotting) that may make myeloma cells more susceptible to chemotherapy. It is not an anti-tumor drug and only has a significant effect on myeloma when combined with cancer-fighting drugs.  Defibrotide may decrease blood clotting and nerve damage caused by certain myeloma treatments. In combination with granulocyte colony-stimulating factor (G-CSF), …

A recent study suggests that the addition of defibrotide to the combination regimen of melphalan (Alkeran), prednisone, and thalidomide (Thalomid) may result in fewer side effects in multiple myeloma patients. The Phase 1 clinical trial results were recently published in the journal Haematologica.

With the development of multiple myeloma therapies, the traditional melphalan-prednisone (MP) treatment regimen has been combined with substances such as Velcade (bortezomib) and thalidomide for more effective results. In particular, clinical trials have shown that these new combination treatments produce greater responses in patients …