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

Discover Clinical Data

Bruce • 58 years old

Experiencing an indolent first relapse

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 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.^†‡

Hypothetical patient

Find Real-World Data

Alice • 75 years old

Active elderly grandmother at first relapse

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 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 was 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 profile^1,2

After shared decision-making with her oncologist, Alice chose the NINLARO^® (ixazomib) triplet regimen.^†‡

Hypothetical patient

FIND SAFETY DATA

Mike • 76 years old

Elderly veteran with comorbidities experiencing first relapse

The NINLARO triplet regimen could help Mike.

The NINLARO triplet regimen* demostrated a safety profile appropiate for long-term^† treatment.

Mike has comorbidities and has been experiencing relapse symptoms.

Reason for clinic visit

Patient had been experiencing new-onset back pain and generalized fatigue

Diagnosis

Diagnosed with MM 4 years ago; R-ISS stage II
Patient has a history of CVD/type 2 diabetes/CKD

Treatment history

Initially treated with an anti-CD38 antibody + immunomodulator + steroid
Treated for 25 months; achieved best response of CR
Treatment was continued with an immunomodulator as maintenance therapy
He is not lenalidomide refractory

Laboratory results

ECOG PS: 1
Atrial fibrillation: Now controlled 90 bpm. Tachycardia at 124 bpm
Blood pressure: 155/90 mmHg
Hemoglobin: 10.3 mg/dL
Serum creatinine: 1.1 mg/dL
Serum calcium: 11.7 mg/dL
Serum M protein: 1.2 g/dL
Skeletal imaging: One new lytic lesion
Cytogenetics/FISH: Negative for high-risk features

Mike’s goals

Like many elderly people with cancer, Mike wants to maintain his independence⁷
He wants a therapy that may allow him to maintain his lifestyle while maximizing therapeutic benefit
An option with convenient dosing (without the need for regular travel to VA medical facility) and manageable tolerability, given his complex medical needs, is important to him

His doctor recommended a therapy that can:

Significantly delay disease progression¹
Fit into his lifestyle with the convenience of an all-oral triplet regimen^†1,8,9
Offer a generally tolerable safety profile^1,2

After shared decision-making with his oncologist, Mike chose the NINLARO^® (ixazomib) triplet 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; VA=Veterans Affairs; VGPR=very good partial response.

Treatment trends in multiple myeloma

Proteasome inhibition remains a cornerstone of multiple myeloma treatment with optimal outcomes.

Learn About Outcomes

NINLARO real-world studies

Real-world evidence can complement data from clinical trials.

Get Study Results

NINLARO safety profile

The NINLARO regimen: a PI triplet with safety similar to the Rd regimen.

Find Safety Data

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Thrombocytopenia has been reported with NINLARO. Platelet nadirs typically occurred between Days 14-21 of each 28-day cycle and recovered to baseline by the start of the next cycle. Grade 3 thrombocytopenia was reported in 17% of patients in the NINLARO regimen and Grade 4 thrombocytopenia was reported in 13% in the NINLARO regimen. During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the first three cycles. Manage thrombocytopenia with dose modifications and platelet transfusions as per standard medical guidelines.

Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea resulted in the discontinuation of one or more of the three drugs in 3% of patients in the NINLARO regimen and 2% of patients in the placebo regimen. Adjust dosing for Grade 3 or 4 symptoms.

Peripheral Neuropathy was reported with NINLARO. The most commonly reported reaction was peripheral sensory neuropathy (24% and 17% in the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (<1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 4% of patients in the NINLARO regimen and <1% of patients in the placebo regimen. During treatment, monitor patients for symptoms of neuropathy and consider adjusting dosing for new or worsening peripheral neuropathy.

Peripheral Edema was reported with NINLARO. Evaluate for underlying causes and provide supportive care, as necessary. Adjust dosing of NINLARO for Grade 3 or 4 symptoms or dexamethasone per its prescribing information.

Cutaneous Reactions. Stevens-Johnson syndrome and toxic epidermal necrolysis, including fatal cases, have been reported with NINLARO. If Stevens-Johnson syndrome or toxic epidermal necrolysis occurs, discontinue NINLARO and manage as clinically indicated. Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Rash resulted in discontinuation of one or more of the three drugs in <1% of patients in both regimens. Manage rash with supportive care or with dose modification if Grade 2 or higher.

Thrombotic Microangiopathy has been reported with NINLARO. Fatal cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), have been reported in patients who received NINLARO. Monitor for signs and symptoms of TTP/HUS. If the diagnosis is suspected, stop NINLARO and evaluate. If the diagnosis of TTP/HUS is excluded, consider restarting NINLARO. The safety of reinitiating NINLARO therapy in patients previously experiencing TTP/HUS is not known.

Hepatotoxicity has been reported with NINLARO. Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in <1% of patients treated with NINLARO. Hepatotoxicity has been reported (10% in the NINLARO regimen and 9% in the placebo regimen). Monitor hepatic enzymes regularly and adjust dosing for Grade 3 or 4 symptoms.

Embryo-fetal Toxicity: NINLARO can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with NINLARO and for 90 days following the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with NINLARO and for 90 days following the last dose.

Increased Mortality in Patients Treated with NINLARO in the Maintenance Setting: In two prospective randomized clinical trials in multiple myeloma in the maintenance setting, treatment with NINLARO resulted in increased deaths. Treatment of patients with NINLARO for multiple myeloma in the maintenance setting is not recommended outside of controlled trials.

ADVERSE REACTIONS

The most common adverse reactions (≥ 20%) in the NINLARO regimen compared to placebo in combination with lenalidomide plus dexamethasone, respectively were thrombocytopenia (85%, 67%; pooled from adverse event and laboratory data), neutropenia (74%, 70%; pooled from adverse event and laboratory data), diarrhea (52%, 43%), constipation (35%, 28%), peripheral neuropathy (32%, 24%), nausea (32%, 23%), edema peripheral (27%, 21%), rash (27%, 16%), vomiting (26%, 13%), and bronchitis (22%, 17%). Serious adverse reactions reported in ≥ 2% of patients in the NINLARO regimen included diarrhea (3%), thrombocytopenia (2%), and bronchitis (2%).

DRUG INTERACTIONS:

Avoid concomitant administration of NINLARO with strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during treatment with NINLARO and for 90 days after the last dose.

Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment.

Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-217-6468 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Patient Profiles: Meet the Kinds of Patients With Relapsed Multiple Myeloma Who May Be Appropriate for NINLARO^® (ixazomib)

Bruce • 58 years old

Experiencing an indolent first relapse

Alice • 75 years old

Active elderly grandmother at first relapse

Mike • 76 years old

Elderly veteran with comorbidities experiencing first relapse

Treatment trends in multiple myeloma

NINLARO real-world studies

NINLARO safety profile

IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS

INDICATION AND USAGE