Patient Profiles: Meet the Kinds of Patients With Relapsed Multiple Myeloma Who May Be Appropriate for NINLARO® (ixazomib)
There are different types of patients with relapsed multiple myeloma who may be appropriate for the NINLARO triplet regimen.*1
*The NINLARO regimen included NINLARO + lenalidomide + dexamethasone. The Rd regimen included placebo + lenalidomide + dexamethasone.1
Hypothetical patient
The NINLARO triplet regimen could help Bruce.
The TOURMALINE-MM1 clinical trial evaluated the efficacy and safety of the all-oral NINLARO regimen, demonstrating prolonged PFS vs Rd regimen.*1,2
Bruce • 58 years old • Experiencing an indolent first relapse
Bruce is experiencing no clinical symptoms, and his M protein levels have been increasing slowly over the past 4 months.
Reason for clinic visit
- Follow-up visit (quarterly)
- No clinical symptoms were present
Diagnosis
- Diagnosed with multiple myeloma 3.5 years ago; R-ISS stage I
Treatment history
- First line of therapy was PI + immunomodulator + steroid, followed by ASCT
- Patient achieved a VGPR
- Bruce received immunomodulator therapy for 2 years
- He is not lenalidomide refractory
Laboratory results
- ECOG PS: 0
- Hemoglobin: 11.7 g/dL
- Serum creatinine: 0.9 mg/dL
- Serum calcium: 10.3 mg/dL
- Serum M protein:
- June: 1.1 g/dL
- July: 1.3 g/dL
- August: 1.6 g/dL
- Skeletal imaging: no new lytic lesions detected
- Cytogenetics/FISH: no adverse cytogenetics
Bruce's goals
- Bruce wanted to keep doing the things that matter to him
- He wanted a treatment option that could help delay his disease progression
- Bruce’s oncologist recommended an option that could deliver extended efficacy, manageable tolerability, and convenient dosing1
After shared decision-making with his oncologist, Bruce chose the NINLARO® (ixazomib) regimen.†‡
†The NINLARO regimen included NINLARO + lenalidomide + dexamethasone.
‡Please see efficacy, safety, and dosing information for NINLARO.
ASCT=autologous stem cell transplant; ECOG PS=Eastern Cooperative Oncology Group performance status; FISH=fluorescence in situ hybridization; PI=proteasome inhibitor; R-ISS=revised International Staging System; VGPR=very good partial response.
Hypothetical patient
The NINLARO triplet regimen could help Alice.
NINLARO has data from real-world studies whose participants reflect patients seen in clinical practice.1-6
Alice • 75 years old • Active elderly grandmother at first relapse
Alice has been experiencing relapse symptoms, so her physician is considering a triplet regimen.
Reason for clinic visit
- Patient has been experiencing new-onset back pain and generalized fatigue
Diagnosis
- Diagnosed with multiple myeloma 3.5 years ago; R-ISS stage I
- Patient had a history of hypertension
Treatment history
- Initially treated with an anti-CD38 antibody + immunomodulator + steroid
- Treated for 25 months; achieved best response of CR
- Treatment continued with an immunomodulator as maintenance therapy
- She is not lenalidomide refractory
Laboratory results
- ECOG PS: 1
- Hemoglobin: 9.5 g/dL
- Serum creatinine: 1.1 mg/dL
- Serum calcium: 10.5 mg/dL
- Serum M protein: 1.2 g/dL
- Skeletal imaging: one new lytic lesion
- Cytogenetics/FISH: negative for high-risk features
Alice's goals
- Like many elderly cancer patients, Alice wants to maintain her independence7
- She wants a therapy that may allow her to live longer without her disease getting worse and without compromising her lifestyle
- An option with convenient dosing and manageable tolerability is important to her
Her doctor recommended a therapy that can:
- Significantly delay disease progression1
- Fit into her lifestyle with the convenience of an all-oral triplet regimen†1,8,9
- Offer a generally tolerable safety profile1,2
After shared decision-making with her oncologist, Alice chose the NINLARO® (ixazomib) triplet regimen.†‡
ECOG=Eastern Oncology Cooperative Group performance status; FISH=fluorescence in situ hybridization; PI=proteasome inhibitor; R-ISS=revised International Staging System; VGPR=very good partial response.
Meet Joe, a real patient taking NINLARO® (ixazomib)
Joe's Indolent First Relapse Journey
"NINLARO gave me the ability to say, ‘Hey, I can still work. I can still travel.’ I can take my treatment with me and be able to work and have more of a full life from that possibility."
- Joe, a real patient taking the all-oral NINLARO regimen,* which does not require clinic visits for dosing1*
*NINLARO + lenalidomide + dexamethasone.
Individual results may vary
ViewHide Transcript
[Text on screen]
This video features a real patient sharing his experience living with multiple myeloma and being treated with NINLARO®. The information in this video is based on his experience at the time of recording. Given the nature of multiple myeloma, experiences may change over time. This is Joe’s experience while taking NINLARO, and yours may be different.
[No voiceover]
JOE: I've been married for 48 years. We normally are early risers, so we get up anywhere from 5:30 to 6:30 in the morning.
We like to exercise as a way to keep ourselves active and keep our bodies active, and I feel it's important with my multiple myeloma to make sure that I keep myself in shape and maintain a good health.
JOE: My name is Joe, I'm 69 years old and I'm living with multiple myeloma.
Before I was diagnosed with multiple myeloma, I had really no serious illnesses or complaints or problems at all.
[No voiceover]
JOE: That's when he told us that I had, sorry, multiple myeloma and that was a shock. He brought in the whole team. He explained everything. He told me that I had two lesions on each of my femurs with the 30% bone loss and that it was something that I needed to take a look at now, not something that I could wait a year on. He said he would suggest that I go ahead and got into the protocol for a stem cell transplant and we kind of left the office that day in shock.
[No voiceover]
JOE: It was after the 100-day mark of getting the post stem cell transplant analysis, that it was kind of another shock as they came up and said that the results indicated I did not go into remission. It was a partial response. The numbers were low but not into, not zero. But then around the four-month mark, the numbers started to go up.
[No voiceover]
JOE: My numbers steadily kept going up and we were talking with the care team about what's the next step and what kind of treatments were out there. They talked about this drug NINLARO.
VO: NINLARO is a prescription medicine used to treat multiple myeloma in combination with the medicines, REVLIMID (lenalidomide) and dexamethasone in people who have received at least one prior treatment for their multiple myeloma. NINLARO should not be used to treat the following people unless they're participants in a controlled clinical trial: people who are receiving maintenance treatment or people who have been newly diagnosed with multiple myeloma. It is not known if NINLARO is safe and effective in children.
VO: Please see Important Safety Information for NINLARO at the end of this video.
[No voiceover]
JOE: I've been on NINLARO now five years. And I got to say I'm extremely happy with the results so far. In my experience taking NINLARO, the side effects have really been very minimal.
VO: The most common side effects of NINLARO include low platelet counts, low white blood cell counts, diarrhea, constipation, nerve problems, nausea, swelling, rash, vomiting, and bronchitis.
JOE: I mean, to me it's just the freedom to be able to conduct your life more independently and on your own. To be able to say, "You know, if I want to go somewhere today, I can go there and I can take this oral pill with me if I hadn't taken it yet." Versus, "Oh, I need to plan around the fact that I've got to be at the hospital tomorrow to get an infusion."
JOE: It was like the best of both worlds.
NINLARO gave me the ability to say, "Hey, I can still work. I can still travel. I don't have to be home and in the hospital on these days of the week and then try to get out on the road on the rest of the week. I can take my treatment with me and be able to work and have more of a full life from that possibility."
JOE: We have a bucket list for my wife and I. We're looking at going to different hockey games where the Pittsburgh Penguins play and seeing every stadium they play in. And at the same time mix that in with seeing the grandsons and watching them grow up and playing their sports and doing their things. So there’s some big plans we have.
JOE: With taking an oral medication versus an infusion, the ability to have freedom to conduct my life and lifestyle in a more normal manner.
Life with multiple myeloma has taught me that you need to value your experience and your life as it is and concentrate on those things that are important to you and your family.
VO: What is NINLARO?
NINLARO is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone, in people who have received at least one prior treatment for their multiple myeloma.
NINLARO should not be used to treat the following people, unless they are participants in a controlled clinical trial:
people who are receiving maintenance treatment, or
people who have been newly diagnosed with multiple myeloma.
It is not known if NINLARO is safe and effective in children.
Important Safety Information for NINLARO® (ixazomib)
NINLARO may cause serious side effects, including:
Low platelet counts (thrombocytopenia) are common with NINLARO and can sometimes be serious. You may need platelet transfusions if your counts are too low. Tell your healthcare provider if you have any signs of low platelet counts, including bleeding and easy bruising.
Stomach and intestinal (gastrointestinal) problems. Diarrhea, constipation, nausea, and vomiting are common with NINLARO and can sometimes be severe. Call your healthcare provider if you get any of these symptoms and they do not go away during treatment with NINLARO. Your healthcare provider may prescribe medicine to help treat your symptoms.
Nerve problems are common with NINLARO and may also be severe. Tell your healthcare provider if you get any new or worsening symptoms including: tingling, numbness, pain, a burning feeling in your feet or hands, or weakness in your arms or legs.
Swelling is common with NINLARO and can sometimes be severe. Tell your healthcare provider if you develop swelling in your arms, hands, legs, ankles, or feet, or if you gain weight from swelling.
Skin reactions. Rashes are common with NINLARO. NINLARO can cause rashes and other skin reactions that can be serious and can lead to death. Tell your healthcare provider right away if you get a new or worsening rash, severe blistering or peeling of the skin, or mouth sores.
Thrombotic microangiopathy (TMA). This is a condition involving blood clots and injury to small blood vessels that may cause harm to your kidneys, brain, and other organs, and may lead to death. Get medical help right away if you get any of the following signs or symptoms during treatment with NINLARO: fever, bruising, nose bleeds, tiredness, or decreased urination.
Liver problems. Tell your healthcare provider if you get these signs of a liver problem: yellowing of your skin or the whites of your eyes; pain in your right upper-stomach area.
Other common side effects of NINLARO include low white blood cell counts and bronchitis.
Tell your healthcare provider if you get new or worsening signs or symptoms of the following during treatment with NINLARO:
skin rash and pain (shingles) due to reactivation of the chicken pox virus (herpes zoster)
blurred vision or other changes in your vision, dry eye, and pink eye (conjunctivitis)
These are not all the possible side effects of NINLARO. Talk to your healthcare provider for medical advice about side effects. You may report side effects to Takeda at 1-844-217-6468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before taking NINLARO, tell your healthcare provider about all your medical conditions, including if you:
have liver problems.
have kidney problems or are on dialysis.
are pregnant or plan to become pregnant. NINLARO can harm your unborn baby.
Females who are able to become pregnant:
Avoid becoming pregnant during treatment with NINLARO.
Your healthcare provider will do a pregnancy test before you start treatment with NINLARO.
You should use effective non-hormonal birth control during treatment and for 90 days after your last dose of NINLARO. If using hormonal contraceptives (for example, birth control pills), you should also use an additional barrier method of contraception (for example, diaphragm or condom). Talk to your healthcare provider about birth control methods that may be right for you during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with NINLARO.
Males with female partners who are able to become pregnant:
You should use effective birth control during treatment and for 90 days after your last dose of NINLARO.
Tell your healthcare provider right away if your partner becomes pregnant or thinks she may be pregnant while you are being treated with NINLARO.
are breastfeeding or plan to breastfeed. It is not known if NINLARO passes into breast milk, if it affects an infant who is breastfed, or breast milk production. Do not breastfeed during treatment with NINLARO and for 90 days after your last dose of NINLARO.
Taking too much NINLARO (overdose) can cause serious side effects, including death. If you take more NINLARO than instructed by your healthcare provider, call your healthcare provider right away or go to the nearest hospital emergency room right away. Take your medicine pack with you.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements or before starting any new medicines. Talk to your healthcare provider before starting any new medicines during treatment with NINLARO.
Please visit NINLARO.com for full Prescribing Information including Patient Information.
Treatment trends in multiple myeloma
Proteasome inhibition remains a cornerstone of multiple myeloma treatment with optimal outcomes.
NINLARO real-world studies
Real-world evidence can complement data from clinical trials.
NINLARO safety profile
The NINLARO regimen: a PI triplet with safety similar to the Rd regimen.