← Back to Search

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

Summary

This trial will test the new combination therapy of ixazomib and dexamethasone to see if it is effective in treating patients with smoldering multiple myeloma.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
best response

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

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
~2640

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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,737 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,153 Patients Enrolled for Multiple Myeloma
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,900 Total Patients Enrolled
82 Trials studying Multiple Myeloma
10,048 Patients Enrolled for Multiple Myeloma
Sham Mailankody, MBBSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
68 Total Patients Enrolled
4 Trials studying Multiple Myeloma
68 Patients Enrolled for Multiple Myeloma

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02697383 — Phase 1
Multiple Myeloma Research Study Groups: Ixazomib (MLN9708) and Dexamethasone
Multiple Myeloma Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT02697383 — Phase 1
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02697383 — Phase 1
~1 spots leftby Jul 2025