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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
My condition is high-risk smoldering multiple myeloma.
Select...
I am registered in the Revlimid REMS program.
Select...
I agree to use protection or abstain from sex if my partner can get pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Combined Modality Therapy
Secondary outcome measures
Duration of Response
Objective Response Rate
Overall Survival
+2 moreSide effects data
From 2021 Phase 4 trial • 45 Patients • NCT0341637426%
Diarrhoea
23%
White blood cell count decreased
21%
Platelet count decreased
15%
Neutrophil count decreased
13%
Pneumonia
8%
Rash
8%
Anaemia
8%
Constipation
8%
Malaise
8%
Pyrexia
5%
Acute kidney injury
5%
Nasopharyngitis
5%
Influenza
3%
Pneumonia bacterial
3%
Tumour lysis syndrome
3%
Febrile neutropenia
3%
Prinzmetal angina
3%
Bile duct stone
3%
Gastroenteritis
3%
Interstitial lung disease
3%
Taste disorder
3%
Enterocolitis
3%
Duodenal ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
[Overall]; Combination Therapy + Ixazomib Therapy
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
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
~2590
Ixazomib
2017
Completed Phase 4
~3370
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
CelgeneIndustry Sponsor
636 Previous Clinical Trials
128,916 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,808 Patients Enrolled for Multiple Myeloma
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,207 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,178 Patients Enrolled for Multiple Myeloma
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,817 Total Patients Enrolled
51 Trials studying Multiple Myeloma
34,267 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience significant numbness, weakness, or pain in my hands or feet.I haven't taken any strong medication that affects liver enzymes within the last 14 days.I don't have any stomach or intestine problems that could affect how a medicine is absorbed.Your M protein level keeps getting higher.My condition is high-risk smoldering multiple myeloma.I am 18 years old or older.I am not currently receiving any experimental treatments.I am registered in the Revlimid REMS program.I do not show signs of active multiple myeloma.My myeloma has spread to my brain or spinal cord.I agree to use protection or abstain from sex if my partner can get pregnant.I am a woman who cannot become pregnant or I am committed to using birth control.I am allergic to medications similar to ixazomib or lenalidomide.You have a current viral infection with HIV, HBV, or HCV.I have been treated with or participated in a study involving ixazomib.I have not had major surgery in the last 2 weeks.My condition involves amyloid proteins.I do not have any unmanaged ongoing illnesses.I haven't had or been treated for another cancer in the last 2 years.I agree to follow the pregnancy testing schedule as required.
Research Study Groups:
This trial has the following groups:- Group 1: Ixazomib
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.
What other investigatory studies have been conducted related to Ixazomib?
"Currently, there are 714 studies actively researching the effects of Ixazomib with 168 trials in Phase 3. In addition to Mishawaka, Indiana, 25978 other sites around the world are running clinical experiments on this drug."
Answered by AI
Are there still vacancies available to participate in this experiment?
"This research endeavour has already concluded recruitment of participants. It was initially posted on October 1st, 2016 and last updated on September 18th, 2022. However, for those still interested in participating in such studies about smoldering multiple myeloma there are currently 808 active trials and 714 related to Ixazomib that are presently enrolling patients."
Answered by AI
What medical maladies has Ixazomib been demonstrated to ameliorate?
"Ixazomib has been approved for use in the treatment of ophthalmia, sympathetic. It can also be prescribed to treat conditions such as branch retinal vein occlusion and macular edema that have not responded positively to two prior systemic chemotherapy regimens."
Answered by AI
Has the FDA sanctioned Ixazomib for therapeutic use?
"There is a limited amount of evidence to suggest ixazomib's safety, thus it has been assigned a score of 2."
Answered by AI
What cap has been placed on participant numbers for this research endeavor?
"This clinical trial is not currently accepting patients. Initially posted on October 1st, 2016 and last edited September 18th 2022, it may be worthwhile to explore the 808 medical trials that are actively recruiting for smoldering multiple myeloma or the 714 studies offering Ixazomib treatments."
Answered by AI
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