Before I situation along important information about Takeda’s of recent origin oral proteasome inhibitor, Ninlaro (ixazomib), I wanted to participate in an update about how I’m doing.
Much more completely, thank you very much! Squirting a shot of vancomycin liquid into the back of my orifice (yuck) every six hours seems to exist doing the trick. Another antibiotic, Flagyl, is usually tried primary in C. diff patients. But my doctors didn’t privation to mess around and used the weighty artillery right away.
My fever is gone. I be moved like myself again. Still need to good stroke the porcelain God every hour or two.
I’m scheduled to be discharged tomorrow round noon. A PET scan in the afternoon and I’ll hold up at one of the limited hotels until I see Dr. Tricot up~ Thursday.
Now I remember why I’m in the present life: Did the second transplant squash my myeloma–at minutest for a while? What maintenance therapy does Dr. Tricot obtain in mind?
Funny. We get caught up in the testing schedules, complications and margin effects and lose sight of the swollen picture. Thursday is a reality restrain for me. Hopefully I’ll be back to normal by then; my stamina is getting pretty sore.
So what’s Ninlaro’s fiction. Another proteasome inhibitor? Ho hum. It may not have ~ing as “sexy.” as individual of the new immunotherapies. Guess I’m while guilty as anyone in neglecting recent accounts about Ninlaro here at MMB. But that doesn’t contemptible I don’t think Ninlaro is going to have ~ing a great drug.
Preliminary data shows Ninlaro to have existence effective as a single agent; level better when combined with Revlimid. Although the song are in the same neighborhood for the re~on that the current medical standard of care–Revlimid, Velcade and dexamethasone (RVD)–the anticipation of an all oral therapy food does excite a lot of patients.
No greater quantity weekly trips to the infusion center. Instead, a persistent can take one Ninlaro capsule, once a week, for three weeks adhering/one week off, along with their quotidian Revlimid or Thalomid for the same three weeks on/one week facing.
Combining Ninlaro with Thalomid? My dare say is docs won’t be shy trying the combination. Bet there are (or self-reliance be) a number of studies teaming the pair drugs; thalidomide is still a type of care for use against multiple myeloma in a numerate of budget conscious countries.
Even more appropriate? How about teaming Ninlaro up by Pomalyst (pomalidomide)? Turns out there is more early data about this. And it looks remarkably promising for use in “experienced” or late stage patients that are refractory to Revlimid and/or Velcade.
Now that’s exciting!
Check ~right this article in Medpage Today yesterday:
Pomalidomide and Ixazomib Pair Up in Refractory Myeloma
December 13, 2015 – MEDPAGE TODAY
ORLANDO — Researchers are even now using the new oral proteasome inhibitor ixazomib (Ninlaro), approved regular prior to the American Society of Hematology conference here, in combination with standard management backbones for people diagnosed with unruly and/or relapsed multiple myeloma.
Although the Phase 1 study’s goal was to declare by verdict a tolerated treatment dose, Peter Voorhees, MD, comrade professor of medicine at the University of North Carolina School of Medicine, Chapel Hill, said that of 20 evaluable patients, person patient achieved a very good unjust response and 10 other patients achieved one objective partial response and another three patients achieved infirmity stabilization. Six of the patients progressed.
All five patients through standard risk characteristics achieved a indulgent response, and six of 13 patients by high-risk prognostic factors achieved favorably disposed responses, he reported at the anniversary meeting of the American Society of Hematology.
“Three of the 6 the patients who were stubborn to lenalidomide (Revlimid) and dexamethasone achieved unfair responses with ixazomib and pomalidomide (Pomalyst) through dexamethasone,” Voorhees said. “The prelusory efficacy is promising.”
The cabal also appeared to allow eight fond responses among the 14 patients who were institute to be refractory to sequential lenalidomide and proteasome inhibitor therapy.
“Pomalidomide, ixazomib and dexamethasone be possible to be combined safely,” Voorhees declared, “But moderate to severe hematologic toxicity is hackneyed and requires close monitoring and supportive care.”
He illustrated that some of the patients have remained up~ the body treatment after 22 cycles. “Many of these responses be favored with proven durable, even at the grow less dose cohorts,” he said. In the criterion three plus three dose escalation design, patients tried three different doses of pomalidomide — 2 mg, 3 mg and 4 mg; and three contrasted doses of ixazomib — 2.3 mg, 3 mg and 4 mg; dexamethasone was on these terms at a dose of 40 mg during the term of patients less than 75 years of decline of life; the dose was reduced to 20 mg in favor of patients 75 years of age or older. Dose limiting toxicities — febrile neutropenia — emerged at prescribed portion level 3 and dose level 4, Voorhees uttered.
“Dose level 3 – 4 mg of pomalidomide and 3 mg of ixazomib was well tolerated,” he before-mentioned.
The patients were about 65 years of st~ of life. They had been diagnosed with multiple myeloma beneficial to a median of 5.18 years; nearly 2/3 of the cohort were men, and 77% were Caucasian. All the patients were in ECOG Performance Status of 0-1. About 59% of the 22 patients wilful at baseline were identified as having occult-risk cytogenetics.
Voorhees said that the middle number of prior therapies was three. He related 100% of the 22 patients had been exposed to bortezomib (Velcade), lenalidomide, and corticosteroids. Of the 22 patients evaluable because of safety, 14 have come off study — 11 to be paid to disease progression; two due to each adverse event (a grade 2 motor neuropathy and febrile neutropenia), and the same patient just preferred to leave the study.
Ken Shain, MD, PhD, assistant member at the Moffitt Cancer Center and professor of oncologic sciences at the University of South Florida, Tampa, told MedPage Today, “Ixazomib has been approved hither and thither a week and it is even now being combined with other drugs, similar to always happens, in treating relapsed or cross-grained multiple myeloma.
“Ixazomib as an oral drug is an exciting active element by itself and provides a fiction way that we can dose our patients in a other thing convenient fashion while maintaining efficacy,” he afore~. “I think this is a great way to go. We know that proteasome and IMID (immunomodulatory drugs) are very much effective without significant toxicities. So to exist able to provide an all-nuncupative regimen is really a breakthrough.”
He related that researchers will have to “feel out” whether there is a difference in using ixazomib with pomalidomide or other agents such taken in the character of lenalidomide. “There have been not at all studies comparing the 2 immunomodulatory agents. I would allude to they will serve 2 different lenient populations — early treatment and relapses with lenalidomide combination; and later relapses with pomalidomide combination.”
Shain disclosed appropriate relationships with Celgene, Amgen, and Takeda.
Vorhees disclosed apposite relationships with Millennium, Takeda, and Celgene.
I know Dr. Shain well from my years considered in the state of a patient at Moffitt Cancer Center in Tampa. Good to conceive him getting the recognition he deserves; Ken works truly hard.
A couple of things to apprehend about. First, I’ll admit the poetry don’t knock you over. But remember that the primordial purpose of a Stage 1 chagrin is to identify the maximum secure dose for patients. Since some of the patients were attached lower doses than common sense tells us they should use, chances are they won’t reply as well. So the fact stingily every patient showed some improvement is encouraging.
Second, memorandum that 8 out of 14 patients responded that were already refractory (resistant) to an IMiD (Thalomid, Revlimid) and a proteasome inhibitor (Velcade or Kyprolis).
That’s me! Something tells me I may exist using Ninlaro soon.
My understanding is Takeda is doing ongoing livelihood studies featuring Ninlaro, too. That would subsist very helpful.
Feel good and commemorate smiling! Pat
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