What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those involving proteasome inhibitors like Ixazomib and corticosteroids like Dexamethasone, are associated with several side effects. Proteasome inhibitors can cause peripheral neuropathy, gastrointestinal issues, fatigue, and cytopenias (such as thrombocytopenia, anemia, and neutropenia). Corticosteroids like Dexamethasone may lead to side effects including hyperglycemia, increased risk of infections, mood changes, and gastrointestinal disturbances. Combining these treatments can enhance efficacy but also increases the risk of compounded side effects, necessitating careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma that involve proteasome inhibitors and corticosteroids. Bortezomib, a proteasome inhibitor, has been approved in combination with dexamethasone for initial treatment and relapsed cases. Carfilzomib, another proteasome inhibitor, has also been approved in combination with dexamethasone for relapsed or refractory Multiple Myeloma. Ixazomib, an oral proteasome inhibitor, has been approved for use with lenalidomide and dexamethasone for patients who have received at least one prior therapy. These combinations aim to improve response rates and progression-free survival in patients with Multiple Myeloma.

What other types of research exist?

Promising novel alternatives to Ixazomib and Dexamethasone for Multiple Myeloma patients include: 1) Bortezomib-based regimens, such as Bortezomib, Cyclophosphamide, and Dexamethasone (CyBorD) with or without Daratumumab, which have shown high efficacy and rapid response rates. 2) Carfilzomib-based regimens, such as Carfilzomib, Dexamethasone, and Daratumumab (KdD), which have demonstrated comparable efficacy with more convenient dosing options. 3) Pomalidomide-based regimens, which have shown activity in relapsed or refractory cases with acceptable toxicity profiles.

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Corticosteroid

Ixazomib + Dexamethasone for Smoldering Multiple Myeloma

Phase 1

Waitlist Available

Led By Sham Mailankody, MBBS

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 cycles of treatment (28 day cycle)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the combination of two drugs, ixazomib and dexamethasone, in patients with early-stage multiple myeloma. The goal is to see if these drugs can prevent or delay the disease from getting worse. Ixazomib works by stopping cancer cells from breaking down proteins, and dexamethasone helps reduce inflammation and kill cancer cells.

Who is the study for?

Adults with Smoldering Multiple Myeloma who haven't had prior treatments with proteasome inhibitors, have no severe diseases or infections like HIV or hepatitis, and can perform daily activities (ECOG 0-2). They must not be pregnant, breastfeeding, or on certain drugs that affect the trial medications. Participants need normal organ function and agree to use effective contraception.

What is being tested?

The study is testing the effects of ixazomib combined with dexamethasone on patients with high-risk smoldering multiple myeloma. It aims to understand how well these drugs work together in controlling this condition without causing significant harm.

What are the potential side effects?

Possible side effects include digestive issues, blood clots, nerve damage (like numbness or pain), allergic reactions to the medication components, fatigue, increased risk of infection due to low white blood cell counts, and liver problems indicated by changes in blood tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 cycles of treatment (28 day cycle)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 cycles of treatment (28 day cycle)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 cycles of treatment (28 day cycle) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

best response

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Cerebrospinal fluid leak

Deep Vein Thrombosis

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

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: Ixazomib (MLN9708) and DexamethasoneExperimental Treatment2 Interventions

Patients with high risk SMM will be enrolled on the pilot study and treated with 2 drug combination (Cycles 1-12 Ixazomib at 4 mg weekly on days 1, 8 and 15, and dexamethasone on days 1, 8, 15 and 22 of 28 day cycle); the dexamethasone dose will be 40 mg/week the first 4 cycles, thereafter 20 mg/week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixazomib (MLN9708)

2016

Completed Phase 1

~20

Dexamethasone

2007

Completed Phase 4

~2650

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Proteasome inhibitors, such as Ixazomib, work by blocking the proteasome's function, leading to an accumulation of proteins within cancer cells, causing cell stress and death. Corticosteroids like Dexamethasone reduce inflammation and suppress the immune response, decreasing the proliferation of myeloma cells and enhancing the effectiveness of other treatments. These mechanisms are crucial for effectively targeting cancer cells and managing side effects in Multiple Myeloma patients.

Safety of ixazomib for the treatment of multiple myeloma.