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Corticosteroid
IRD Regimen for Multiple Myeloma
Phase 4
Waitlist Available
Research Sponsored by Millennium Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2 at time of enrollment.
Participants must have completed 3 cycles of a bortezomib-based induction regimen (as defined by current NCCN guidelines) and have no evidence of disease progression as defined by IMWG criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of the first study drug administration to the date of the last administration of any of the 3 study drugs (up to 3 years).
Awards & highlights
Study Summary
This trial is testing if a bortezomib-based induction regimen can improve progression-free survival in myeloma patients.
Who is the study for?
This trial is for adults with Multiple Myeloma who've had a bortezomib-based treatment but no disease progression. They should be ineligible for transplant or not planning one within 24 months, able to perform daily activities (ECOG status 0-2), and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests Ixazomib combined with Lenalidomide and Dexamethasone on patients who have completed prior chemotherapy. It aims to see how this combination affects the progression of Multiple Myeloma over two years in about 160 participants.See study design
What are the potential side effects?
Possible side effects include gastrointestinal symptoms like nausea and diarrhea, low blood counts leading to increased infection risk or bleeding, nerve damage causing numbness or pain, rash, fatigue, and potential liver issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I finished 3 cycles of a specific treatment without my cancer getting worse.
Select...
I have multiple myeloma and have been treated once before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of the first study drug administration to the date of the last administration of any of the 3 study drugs (up to 3 years).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of the first study drug administration to the date of the last administration of any of the 3 study drugs (up to 3 years).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Duration of Ixazomib Therapy
Duration of Proteasome Inhibitor Therapy
Duration of Response
+3 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: Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mgExperimental Treatment3 Interventions
Ixazomib 4 milligram (mg), capsules, orally, once, on Days 1, 8 and 15 and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22 of a 28-day cycle for a maximum of 39 cycles until PD or unacceptable toxicity, whichever occurs first for up to 3 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Lenalidomide
FDA approved
Ixazomib
FDA approved
Find a Location
Who is running the clinical trial?
Millennium Pharmaceuticals, Inc.Lead Sponsor
404 Previous Clinical Trials
46,773 Total Patients Enrolled
82 Trials studying Multiple Myeloma
9,921 Patients Enrolled for Multiple Myeloma
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,121 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,092 Patients Enrolled for Multiple Myeloma
Medical Monitor Clinical ScienceStudy DirectorMillennium Pharmaceuticals, Inc.
5 Previous Clinical Trials
3,575 Total Patients Enrolled
2 Trials studying Multiple Myeloma
1,225 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled heart problems.I can take care of myself and am up and about more than half of my waking hours.I am a woman who cannot become pregnant or will use two birth control methods during the study.I have been diagnosed with multiple myeloma based on all required criteria.I haven't taken specific strong medications or herbal supplements like St. John's wort in the last 14 days.I haven't had any cancer besides nonmelanoma skin cancer or in situ carcinoma, or if I have, it was treated over 2 years ago with no remaining signs.I finished 3 cycles of a specific treatment without my cancer getting worse.I have multiple myeloma and have been treated once before.My stem cell treatment plan has been approved by the Takeda Medical Monitor.My cancer has worsened despite initial treatment.I do not have an active infection or known HIV, hepatitis B, or C.My doctor thinks I can receive the IRD treatment.I have not had a serious infection or needed antibiotics in the last 14 days.I haven't had radiotherapy in the last 14 days, or 7 days if it was a small area.I have moderate to severe nerve damage or mild with pain.My multiple myeloma has spread to my brain or spinal cord.I am a male and agree to use contraception or practice abstinence during and 90 days after the study.I have not had major surgery in the last 14 days.I have been treated with or been part of a study involving ixazomib.I still have mild side effects from my last chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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 openings for individuals to participate in this trial?
"Data from clinicaltrials.gov indicates that this medical trial is currently not accepting any additional participants; its initial posting was on September 20th 2017 and it last updated October 28th 2022. Fortunately, there are still 1,523 other trials actively recruiting at the moment."
Answered by AI
What are the main applications of Ixazomib?
"Ixazomib is effective at managing ophthalmia, sympathetic conditions and branch retinal vein occlusion. Additionally, it can be administered as a part of multiple systemic chemotherapy regimens."
Answered by AI
How many participants are contributing to the results of this clinical research?
"At this time, the trial is not enrolling patients. Although initially posted in September 2017, it was last updated on October 28th 2022. For those looking for similar studies there are 807 trials actively recruiting people with multiple myeloma and 716 clinical investigations searching for volunteers to test Ixazomib treatment."
Answered by AI
How many operational sites are overseeing this trial?
"This on-going medical research is hosted by Texas Oncology - Presbyterian Cancer Center Dallas in Dallas, TX, Texas Oncology - San Antonio Northwest in San Antonio, CA and Cancer Center Associates situated at Mesquite Nevada among 24 other sites."
Answered by AI
Has the FDA approved Ixazomib for clinical use?
"The safety of Ixazomib was rated at 3, which is the highest score possible due to its approval and Phase 4 status."
Answered by AI
Has Ixazomib been evaluated in any other research experiments?
"Ixazomib was first studied nearly two decades ago in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since that initial trial, 1375 additional studies have been completed and 716 further clinical trials are presently enrolling participants, with a majority of these being located in the Dallas region of Texas."
Answered by AI
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