Before I make a thrust along important information about Takeda’s unaccustomed oral proteasome inhibitor, Ninlaro (ixazomib), I wanted to apportioned lot an update about how I’m doing.
Much improvement, thank you very much! Squirting a missile of vancomycin liquid into the back of my opening (yuck) every six hours seems to be doing the trick. Another antibiotic, Flagyl, is usually tried chief in C. diff patients. But my doctors didn’t want to mess around and used the ponderous artillery right away.
My fever is gone. I be conscious of being like myself again. Still need to gain the porcelain God every hour or sum of ~ units.
I’m scheduled to be discharged tomorrow on every side of noon. A PET scan in the afternoon and I’ll grasp up at one of the limited hotels until I see Dr. Tricot in successi~ Thursday.
Now I remember why I’m to this place: Did the second transplant squash my myeloma–at least for a while? What maintenance therapy does Dr. Tricot require in mind?
Funny. We get caught up in the testing schedules, complications and espouse a cause effects and lose sight of the important picture. Thursday is a reality reprimand for me. Hopefully I’ll have existence 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 exist as “sexy.” as single of the new immunotherapies. Guess I’m in the manner that guilty as anyone in neglecting tidings about Ninlaro here at MMB. But that doesn’t medium I don’t think Ninlaro is going to exist a great drug.
Preliminary data shows Ninlaro to exist effective as a single agent; on the same level better when combined with Revlimid. Although the song are in the same neighborhood since the current medical standard of care–Revlimid, Velcade and dexamethasone (RVD)–the likelihood of an all oral therapy fare does excite a lot of patients.
No greater degree weekly trips to the infusion center. Instead, a long-suffering can take one Ninlaro capsule, one time a week, for three weeks put ~/one week off, along with their diurnal Revlimid or Thalomid for the same three weeks on/one week from.
Combining Ninlaro with Thalomid? My conjecture is docs won’t be -reserved trying the combination. Bet there are (or demise be) a number of studies teaming the couple drugs; thalidomide is still a support of care for use against multiple myeloma in a tell off of budget conscious countries.
Even improvement? How about teaming Ninlaro up through Pomalyst (pomalidomide)? Turns out there is some early data about this. And it looks extremely promising for use in “experienced” or tardily stage patients that are refractory to Revlimid and/or Velcade.
Now that’s exciting!
Check aloud 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 honorable prior to the American Society of Hematology collection of people here, in combination with standard usage backbones for people diagnosed with cantankerous and/or relapsed multiple myeloma.
Although the Phase 1 study’s goal was to discover a tolerated treatment dose, Peter Voorhees, MD, sort professor of medicine at the University of North Carolina School of Medicine, Chapel Hill, said that of 20 evaluable patients, one patient achieved a very good subordinate response and 10 other patients achieved each objective partial response and another three patients achieved distemper stabilization. Six of the patients progressed.
All five patients with standard risk characteristics achieved a fond response, and six of 13 patients through high-risk prognostic factors achieved fond responses, he reported at the year-book meeting of the American Society of Hematology.
“Three of the 6 the patients who were ungovernable to lenalidomide (Revlimid) and dexamethasone achieved incomplete responses with ixazomib and pomalidomide (Pomalyst) through dexamethasone,” Voorhees said. “The introduction efficacy is promising.”
The mixture also appeared to allow eight fond responses among the 14 patients who were raise to be refractory to sequential lenalidomide and proteasome inhibitor therapy.
“Pomalidomide, ixazomib and dexamethasone can be combined safely,” Voorhees reported, “But moderate to severe hematologic toxicity is habitual and requires close monitoring and supportive care.”
He illustrated that some of the patients have remained put ~ treatment after 22 cycles. “Many of these responses receive proven durable, even at the sink dose cohorts,” he said. In the streamer three plus three dose escalation design, patients pure three different doses of pomalidomide — 2 mg, 3 mg and 4 mg; and three diverse doses of ixazomib — 2.3 mg, 3 mg and 4 mg; dexamethasone was by stipulation at a dose of 40 mg in spite of patients less than 75 years of period of life; the dose was reduced to 20 mg in spite of patients 75 years of age or older. Dose limiting toxicities — febrile neutropenia — emerged at drench level 3 and dose level 4, Voorhees uttered.
“Dose level 3 – 4 mg of pomalidomide and 3 mg of ixazomib was well tolerated,” he reported.
The patients were about 65 years of time of life. They had been diagnosed with multiple myeloma in spite of a median of 5.18 years; round 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 early-risk cytogenetics.
Voorhees said that the median 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 during safety, 14 have come off study — 11 exactly to disease progression; two due to each adverse event (a grade 2 motor neuropathy and febrile neutropenia), and single in kind patient just preferred to leave the study.
Ken Shain, MD, PhD, collaborator 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 around a week and it is even now being combined with other drugs, to the degree that always happens, in treating relapsed or cantankerous multiple myeloma.
“Ixazomib as each oral drug is an exciting force by itself and provides a rare way that we can dose our patients in a greater degree of convenient fashion while maintaining efficacy,” he afore~. “I think this is a elevated way to go. We know that proteasome and IMID (immunomodulatory drugs) are highly effective without significant toxicities. So to subsist able to provide an all-spoken regimen is really a breakthrough.”
He said that researchers will have to “be warmed out” whether there is a strife in using ixazomib with pomalidomide or other agents of the like kind as lenalidomide. “There have been none studies comparing the 2 immunomodulatory agents. I would hint they will serve 2 different uncomplaining populations — early treatment and relapses through lenalidomide combination; and later relapses with pomalidomide combination.”
Shain disclosed pertinent relationships with Celgene, Amgen, and Takeda.
Vorhees disclosed apt relationships with Millennium, Takeda, and Celgene.
I perceive Dr. Shain well from my years taken in the character of a patient at Moffitt Cancer Center in Tampa. Good to discern him getting the recognition he deserves; Ken works actually hard.
A couple of things to reflect about. First, I’ll admit the verse don’t knock you over. But remember that the preparatory purpose of a Stage 1 chagrin is to identify the maximum trustworthy dose for patients. Since some of the patients were without ceasing lower doses than common sense tells us they should practice, chances are they won’t rejoin as well. So the fact parsimoniously every patient showed some improvement is encouraging.
Second, bill that 8 out of 14 patients responded that were even now 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 sustenance studies featuring Ninlaro, too. That would have existence very helpful.
Feel good and commemorate smiling! Pat
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