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Corticosteroid

IRD Regimen for Multiple Myeloma

Phase 4

Waitlist Available

Research Sponsored by Millennium Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2 at time of enrollment.

Participants must have completed 3 cycles of a bortezomib-based induction regimen (as defined by current NCCN guidelines) and have no evidence of disease progression as defined by IMWG criteria.

Must not have

Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.

Systemic treatment, within 14 days before the first dose of ixazomib, with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of the first study drug administration to the date of the last administration of any of the 3 study drugs (up to 3 years).

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial is testing if a bortezomib-based induction regimen can improve progression-free survival in myeloma patients.

Who is the study for?

This trial is for adults with Multiple Myeloma who've had a bortezomib-based treatment but no disease progression. They should be ineligible for transplant or not planning one within 24 months, able to perform daily activities (ECOG status 0-2), and agree to use effective contraception.

What is being tested?

The study tests Ixazomib combined with Lenalidomide and Dexamethasone on patients who have completed prior chemotherapy. It aims to see how this combination affects the progression of Multiple Myeloma over two years in about 160 participants.

What are the potential side effects?

Possible side effects include gastrointestinal symptoms like nausea and diarrhea, low blood counts leading to increased infection risk or bleeding, nerve damage causing numbness or pain, rash, fatigue, and potential liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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I finished 3 cycles of a specific treatment without my cancer getting worse.

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I have multiple myeloma and have been treated once before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled heart problems.

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I haven't taken specific strong medications or herbal supplements like St. John's wort in the last 14 days.

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My cancer has worsened despite initial treatment.

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I do not have an active infection or known HIV, hepatitis B, or C.

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I have moderate to severe nerve damage or mild with pain.

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My multiple myeloma has spread to my brain or spinal cord.

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I have not had major surgery in the last 14 days.

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I have been treated with or been part of a study involving ixazomib.

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I still have mild side effects from my last chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of the first study drug administration to the date of the last administration of any of the 3 study drugs (up to 3 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of the first study drug administration to the date of the last administration of any of the 3 study drugs (up to 3 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of the first study drug administration to the date of the last administration of any of the 3 study drugs (up to 3 years). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Duration of Ixazomib Therapy

Duration of Proteasome Inhibitor Therapy

Duration of Response

+3 more

Side effects data

From 2021 Phase 4 trial • 45 Patients • NCT03416374

29%

Diarrhoea

24%

White blood cell count decreased

20%

Platelet count decreased

16%

Rash

16%

Neutrophil count decreased

11%

Pneumonia

Constipation

Malaise

Pyrexia

Anaemia

Nasopharyngitis

Decreased appetite

Taste disorder

Acute kidney injury

Influenza

Bile duct stone

Gastroenteritis

Pneumonia bacterial

Bone pain

Febrile neutropenia

Duodenal ulcer

Enterocolitis

Tibia fracture

Interstitial lung disease

Prinzmetal angina

Compression fracture

Spinal compression fracture

Tumour lysis syndrome

100%

80%

60%

40%

20%

Study treatment Arm

[Overall]; Combination Therapy + Ixazomib Therapy

[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy

[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mgExperimental Treatment3 Interventions

Ixazomib 4 milligram (mg), capsules, orally, once, on Days 1, 8 and 15 and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22 of a 28-day cycle for a maximum of 39 cycles until PD or unacceptable toxicity, whichever occurs first for up to 3 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

FDA approved

Lenalidomide

FDA approved

Ixazomib

FDA approved

0 / 12Eligibility criteria met