Pivotal TOURMALINE-MM1 Results Demonstrated that the Addition of Oral Ixazomib to Lena­lido­mide and Dexamethasone Significantly Extended Progression-Free Survival, with Limited Additional Toxicity in Patients with Relapsed/Refractory Multiple Myeloma

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that results from the inter­na­tional, ran­dom­ized, double-blind, placebo-controlled TOURMALINE-MM1 Phase 3 clin­i­cal study, eval­u­ating once-weekly oral NINLARO® (ixazomib) capsules plus lena­lido­mide and dexa­meth­a­sone versus placebo plus lena­lido­mide-dexamethasone in patients with re­lapsed and/or refractory multiple myeloma, have been published in the prestigious New England Journal of Medicine (NEJM). NINLARO was recently approved by the U.S. Food and Drug Admin­istra­tion (FDA), based on the pivotal TOURMALINE-MM1 data, in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of …

Good morning, myeloma world.

Things have settled down here at Myeloma Morning Headquarters compared to how they were 36 hours ago. We once again have 21^st century tech­nology doing what it is supposed to be doing. It's wonderful.

Speaking of wonderful, let's talk some more about the multiple myeloma research to be presented at the upcoming 2016 annual meeting of the American Society of Clinical Oncology (ASCO). We discussed the meeting in the previous edition of Myeloma Morning, noting that ASCO has re­leased the titles – but not the abstracts – …

We hope you had a pleasant Wednesday, myeloma world.

Our Wednesday was going full steam ahead until modern tech­nology at Myeloma Morning Headquarters decided to take a vaca­tion. And this had to hap­pen, of course, on a day when we have some particularly in­ter­est­ing devel­op­ments to discuss.

What “developments” might those be, you ask?

Well, those “developments” would be the titles of all pre­sen­ta­tions to be given at the 2016 annual meeting of the American Society of Clinical Oncology (ASCO). The titles were made public on Wednesday.

In this edition of

Good morning, myeloma world.

As we were finalizing today's edition of Myeloma Morning, we were suddenly reminded of how inter­na­tional the field of multiple myeloma research truly is.

The first research study we review below is by a team of German researchers. We also discuss two studies by Korean researchers, and a topic sparked by a report written by Chinese researchers. At the end of today's report, the list of new myeloma research articles also in­cludes publications by investigators in India, Israel, Italy, and the United States.

As we …

Good morning, myeloma world.

We have a slightly different edition of Myeloma Morning cooked up for you today than is usually the case. Although we have one new myeloma research study that we will review – see the discussion further below about Cometriq – we will spend most of today's edition looking in more detail at an issue discussed in this Monday's edition of Myeloma Morning.

In that article, we discussed a recent study by physicians at the Mayo Clinic's Arizona campus. The Mayo Clinic study concerns a con­di­tion known …

Independent Data Monitoring Committee rec­om­mends Phase 3 trial be stopped early based on pos­i­tive results of planned interim analysis

Raritan, NJ (Press Release) – Janssen Research & Development, LLC announced today pos­i­tive results of a pre-planned interim analysis of the Phase 3 MMY3004 (CASTOR) trial eval­u­ating the efficacy and safety of dara­tu­mu­mab, a CD38-directed mono­clonal anti­body (mAb), in com­bi­na­tion with bor­tez­o­mib and dexa­metha­sone, com­pared to bor­tez­o­mib and dexa­metha­sone alone, in patients with re­lapsed or refractory multiple myeloma. The interim analysis, conducted by an Independent Data Monitoring Committee (IDMC), found that the dara­tu­mu­mab com­bi­na­tion treat­ment regi­men im­proved pro­gres­sion-free survival (PFS) com­pared with bor­tez­o­mib and dexa­metha­sone alone, achieving the pri­mary study end­point …

Good morning, myeloma world.

We hope your week is getting off to a good start. We've got a couple of new research studies to discuss in today's edition of Myeloma Morning, as well as several highlights from the Beacon's discussion forum.

On the research front, we'll start today by mentioning an article by physicians at the Mayo Clinic's Arizona campus. They report on a com­pli­ca­tion, known as thrombotic microangiopathy (TMA), that occurred in two multiple myeloma patients they had treated with Kyprolis (car­filz­o­mib) (abstract).

TMA is a con­di­tion marked …