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Corticosteroid

Ixazomib + Lenalidomide + Dexamethasone for Smoldering Multiple Myeloma

Phase 2

Waitlist Available

Led By Irene M Ghobrial, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Must meet criteria of high risk smoldering MM based on specified criteria

Must not have

Grade 2 peripheral neuropathy or higher or grade 1 with pain on clinical examination during the screening period

Systemic treatment, within 14 days before the first dose of ixazomib with strong CYP3A inducers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it can treat Smoldering Multiple Myeloma, a cancer of the blood.

Who is the study for?

This trial is for adults with high-risk Smoldering Multiple Myeloma who can sign consent, are not pregnant, agree to birth control measures, and have no active major illnesses. Excluded are those with recent surgeries or other treatments, certain infections (HIV/HBV/HCV), another cancer within 2 years (with exceptions), known allergies to similar drugs, or any previous ixazomib treatment.

What is being tested?

The study tests a new drug combo: Ixazomib with Lenalidomide and Dexamethasone in patients with Smoldering Multiple Myeloma. It aims to see if this combination can help manage the condition before it progresses further.

What are the potential side effects?

Possible side effects include digestive issues, blood clots, nerve damage (neuropathy), rash or allergic reactions due to Lenalidomide; fatigue and low blood counts from Dexamethasone; and gastrointestinal symptoms from Ixazomib.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My condition is high-risk smoldering multiple myeloma.

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I am registered in the Revlimid REMS program.

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I agree to use protection or abstain from sex if my partner can get pregnant.

Exclusion Criteria

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

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I experience significant numbness, weakness, or pain in my hands or feet.

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I haven't taken any strong medication that affects liver enzymes within the last 14 days.

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I don't have any stomach or intestine problems that could affect how a medicine is absorbed.

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I am not currently receiving any experimental treatments.

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I do not show signs of active multiple myeloma.

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My myeloma has spread to my brain or spinal cord.

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I am allergic to medications similar to ixazomib or lenalidomide.

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I have been treated with or participated in a study involving ixazomib.

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I have not had major surgery in the last 2 weeks.

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My condition involves amyloid proteins.

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I do not have any unmanaged ongoing illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Combined Modality Therapy

Secondary study objectives

Duration of Response

Objective Response Rate

Overall Survival

+2 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

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: IxazomibExperimental Treatment3 Interventions

* Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Ixazomib

2017

Completed Phase 4

~3510