Ninlaro

Multiple Myeloma
Treatment
2 FDA approvals
6 Active Studies for Ninlaro

What is Ninlaro

IxazomibThe Generic name of this drug
Treatment SummaryIxazomib is an oral medication used to treat multiple myeloma. It is taken in combination with lenalidomide and dexamethasone, and is usually prescribed to patients who have received at least one prior therapy. It works by inhibiting proteasomes (proteins that help break down proteins) and is sold under the brand name Ninlaro. It was found to be as effective as bortezomib (the first proteasome inhibitor approved for multiple myeloma) in controlling myeloma growth and preventing bone loss. The drug was approved by the FDA in 2015.
Ninlarois the brand name
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Ninlaro Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Ninlaro
Ixazomib
2015
6

Approved as Treatment by the FDA

Ixazomib, commonly known as Ninlaro, is approved by the FDA for 2 uses which include Multiple Myeloma and Multiple Myeloma (MM) .
Multiple Myeloma
Used to treat Multiple Myeloma (MM) in combination with Dexamethasone
Multiple Myeloma (MM)
Used to treat Multiple Myeloma (MM) in combination with Dexamethasone

Effectiveness

How Ninlaro Affects PatientsTests done in laboratories have shown that ixazomib can kill multiple myeloma cells. In tests on mice, ixazomib was able to slow down tumor growth.
How Ninlaro works in the bodyIxazomib is a type of medication that stops the 20S proteasome from breaking down proteins. This causes proteins to build up and stop the cell from functioning properly, leading to cell death.

When to interrupt dosage

The amount of Ninlaro is contingent upon the diagnosed affliction. The dosage fluctuates in accordance with the technique of delivery noted in the table below.
Condition
Dosage
Administration
Multiple Myeloma
, 2.3 mg, 3.0 mg, 4.0 mg
, Oral, Capsule, Capsule - Oral

Warnings

There are 20 known major drug interactions with Ninlaro.
Common Ninlaro Drug Interactions
Drug Name
Risk Level
Description
Albutrepenonacog alfa
Minor
Ixazomib may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.
Almasilate
Minor
Ixazomib may decrease the excretion rate of Almasilate which could result in a higher serum level.
Antithrombin III human
Minor
Ixazomib may decrease the excretion rate of Antithrombin III human which could result in a higher serum level.
Baricitinib
Minor
Ixazomib may decrease the excretion rate of Baricitinib which could result in a higher serum level.
Benserazide
Minor
Ixazomib may decrease the excretion rate of Benserazide which could result in a higher serum level.
Ninlaro Toxicity & Overdose RiskLess than 1% of patients taking Ixazomib have reported liver-related illnesses such as liver damage, fatty liver, hepatitis, or bile duct blockage. Taking Ixazomib while pregnant can cause harm to the baby, so it is important for women of reproductive age to avoid becoming pregnant while taking this drug.
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Ninlaro Novel Uses: Which Conditions Have a Clinical Trial Featuring Ninlaro?

11 studies are presently assessing the utility of Ninlaro in the treatment of Multiple Myeloma.
Condition
Clinical Trials
Trial Phases
Multiple Myeloma
6 Actively Recruiting
Phase 1, Phase 2

Ninlaro Reviews: What are patients saying about Ninlaro?

5Patient Review
10/25/2018
Ninlaro for Multiple Myeloma
I just finished my seventh cycle of this treatment, and it was much more tolerable than Pomalyst, Kyprolis, or Velcade. That being said, all of those treatments worked for me in one way or another.
1Patient Review
10/16/2016
Ninlaro for Multiple Myeloma
I will update this review in three weeks after taking the medication for an extended period of time.
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Patient Q&A Section about ninlaro

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How long does it take NINLARO to work?

"The median time it took for patients to see their first response was shorter when taking the NINLARO regimen compared to the placebo regimen. However, it should be noted that it took longer for some patients to see a response."

Answered by AI

Is NINLARO the same as Velcade?

"The drugs Ninlaro and Velcade are both targeted therapies for multiple myeloma that work in the same way by inhibiting proteasomes."

Answered by AI

Is NINLARO a chemotherapy drug?

"The anticancer drug Ninlaro is used to treat multiple myeloma. It is used in combination with the drugs lenalidomide and dexamethasone."

Answered by AI

What are the side effects of NINLARO?

"The following text describes some of the possible side effects of a medication. Diarrhea, nausea, vomiting, constipation, dry eyes, blurred vision, or eye redness/itching/discharge may occur. These side effects can be severe in some cases. To prevent or relieve these side effects, your doctor may prescribe medication."

Answered by AI

Clinical Trials for Ninlaro

Image of Abramson Cancer Center at University of Pennsylvania in Philadelphia, United States.

Limited-duration Teclistamab for Multiple Myeloma

18+
All Sexes
Philadelphia, PA
This is a single-arm, non-inferiority study in which patients who have achieved a very good partial response (VGPR) or better, according to International Myeloma Working Group (IMWG) response criteria, following 6 to 9 months of treatment with teclistamab, a B-cell maturation antigen (BCMA)-directed T-cell engager (anti-BCMAxCD3 bispecific antibody), will be offered monitored drug discontinuation. Teclistamab is typically dosed on a regular schedule (every 1-4 weeks) indefinitely until disease progression ("continuous therapy"). Here, a limited-duration regimen will be studied in which patients achieving ≥VGPR after 6-9 months of standard teclistamab dosing will discontinue therapy and resume if laboratory or clinical parameters suggest early disease progression ("limited-duration therapy"). Patients will enter the clinical trial protocol after completing 6-9 months of standard teclistamab monotherapy and achieving ≥VGPR. The study's hypothesis is that the failure probability six months after stopping teclistamab in this patient population will be non-inferior compared to that of historical controls treated with continuous therapy. Reducing drug exposure may be beneficial by reducing risk of infection and reducing anti-BCMA selective pressure toward generation of BCMA-negative relapses. Analysis of minimal residual disease (MRD), tumor features, and bone marrow microenvironment parameters, which will be pursued as exploratory correlative analyses in this study, may identify factors that predict durable response to limited-duration therapy and thereby enable more precise selection of patients likely to benefit from this approach. A subset of patients will be enrolled on a biomarker study for analysis of these exploratory endpoints.
Phase 2
Recruiting
Abramson Cancer Center at University of Pennsylvania (+4 Sites)Alfred Garfall, MD
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Image of National Institutes of Health Clinical Center in Bethesda, United States.

BCMA CAR-T Cell Therapy for Multiple Myeloma

18 - 73
All Sexes
Bethesda, MD
Background: Multiple myeloma is a cancer of the blood plasma cells. It usually becomes resistant to standard treatments. Researchers have developed a procedure called gene therapy. It uses a person's own T cells, which are part of the immune system. The cells are changed in a lab and then returned to the person. Researchers hope the changed T cells will be better at recognizing and killing tumor cells. Objective: To test the safety of giving changed T cells to people with multiple myeloma. Eligibility: Adults ages 18-73 who have been diagnosed with multiple myeloma that has not been controlled with standard therapies. Design: Participants will be screened with: Medical history Physical exam Blood tests Heart function tests Bone marrow sample taken by needle in a hip bone. Scan of the chest, abdomen, and pelvis. They may have a brain scan. Pregnancy test Participants will have apheresis. Blood will be removed through an arm vein. The blood will be separated, and T cells removed. The rest of the blood will be returned through a vein in the other arm. Participants will have a central line placed in a large vein in the arm or chest. Participants will get 2 chemotherapy drugs by the central line over 3 days. Two days later, participants will get the changed T cells by the central line. They will stay in the hospital at least 9 days. Participants must stay near the hospital for 2 weeks. Participants will have 8 follow-up visits over the next year for blood and urine tests. They may have scans. Participants blood will be collected regularly over the next several years.
Phase 1
Waitlist Available
National Institutes of Health Clinical CenterJames N Kochenderfer, M.D.
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