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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
Study 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 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)
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 • NCT014749152%
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
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,937 Previous Clinical Trials
588,306 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with multiple myeloma.I have been treated for smoldering multiple myeloma with a proteasome inhibitor.I haven't been in a clinical trial for my smoldering myeloma that conflicts with this trial's timing.My blood pressure or diabetes is not well-managed.I am not allergic or unable to take medications needed before my cancer treatment.I haven't had or been treated for another cancer within the last 2 years.I am not pregnant or breastfeeding.I have a stomach or intestine condition that affects my ability to take pills.I have nerve pain in my hands or feet.I have a heart condition that is not currently under control.I do not have an active infection, HIV, or active hepatitis B or C.I haven't taken strong medication inhibitors or certain herbal supplements in the last 14 days.My kidneys work well enough (creatinine clearance > 30 mL/min).Your heart's electrical activity takes too long to reset between beats, as measured by a heart test.I still have side effects from my last chemotherapy.I haven't needed antibiotics for an infection in the last 14 days.You do not have anemia caused by a specific disorder, which means your hemoglobin level is above 10 g/dl or not more than 2 g/dL below the lower limit of normal.You have more than one specific spot on your MRI scan.I have been treated with or been in a study for ixazomib before.You have a high level of a protein called M-protein in your blood or a high amount of plasma cells in your bone marrow.Your blood calcium level is not too high.Your blood test shows a specific ratio of certain proteins that is too high.I am a male willing to use contraception or practice abstinence during the study.I am 18 years old or older.I can take care of myself and perform daily activities.I am a woman who cannot become pregnant or agrees to use 2 forms of birth control or practice abstinence.You have specific levels of proteins in your blood or urine that show the disease is present.I can take pills and follow treatment instructions without any issues.I have not had major surgery in the last 2 weeks.I have not had radiotherapy in the last 14 days.I do not have any severe illnesses that would affect my participation in the study.My cancer has spread to my brain or spinal cord.My condition is confirmed as Smoldering Multiple Myeloma by a pathology department.I am not currently on bisphosphonate therapy for myeloma.Your bone marrow does not have a high percentage of abnormal plasma cells.I have Paget's disease of the bone.I do not have any bone damage from cancer.My blood counts and liver function tests are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Ixazomib (MLN9708) and Dexamethasone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to get involved in this experiment?
"Currently, this trial is not seeking participants. It was published on February 1st 2016 and most recently updated November 15th 2022. If you are looking for alternative studies, there are 808 trials that involve the treatment of multiple myeloma and 575 clinical trials recruiting patients to use Dexamethasone as therapy."
Answered by AI
What prior research has been conducted utilizing Dexamethasone?
"Currently, 575 trials are investigating the effects of Dexamethasone. Of these active studies, 147 have progressed to Phase 3. The primary site for this research is Mishawaka Indiana however there are 19336 other locations running experiments related to this medication."
Answered by AI
How many healthcare facilities are presently conducting this research?
"This study is enrolling patients from six different medical sites, including Memorial Sloan Kettering Commack in Commack, Montvale's Memoral Sloan Kettering Bergen, and the Basking Ridge branch of the same cancer center."
Answered by AI
How many participants are signed up for this trial?
"Unfortunately, this study is no longer recruiting. It was initially posted on February 1st 2016 and the latest update happened November 15th 2022. However, there are plenty of other trials actively looking for participants with multiple myeloma (808) or Dexamethasone (575)."
Answered by AI
What medical purpose does Dexamethasone typically serve?
"Dexamethasone can be used to address ophthalmia, sympathetic eye inflammation, and branch retinal vein occlusion."
Answered by AI
What potential side effects accompany the consumption of Dexamethasone?
"The safety of Dexamethasone was scored a 1, given that it is in Phase 1 trials and the available data on both efficacy and harm mitigation are limited."
Answered by AI
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