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Lenalidomide for Multiple Myeloma

Phase 2
Waitlist Available
Led By James R. Berenson M Inc., MD
Research Sponsored by Oncotherapeutics
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 through study completion, approximately 5 years
Awards & highlights

Study Summary

This trial is testing ixazomib alone and in combination with lenalidomide as maintenance therapy for patients with multiple myeloma who have responded to initial treatment with a bortezomib- and lenalidomide-containing combination.

Eligible Conditions
  • Newly Diagnosed Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events (AEs)
PFS
Secondary outcome measures
Deepening of the response
OS

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ixazomib OnlyExperimental Treatment1 Intervention
The prescribed dose administration of ixazomib in this study is 3mg orally on Days 1, 8, and 15 of a 28-day cycle.
Group II: Ixazomib + LenalidomideExperimental Treatment2 Interventions
The prescribed dose administration of ixazomib in this study is 3mg orally on Days 1, 8, and 15 of a 28-day cycle. The prescribed dose administration of lenalidomide in this study is the same as the dose of the patient's front-line treatment taken in the last treatment cycle unless otherwise clinically indicated per investigator's discretion, taken orally on days 1-28 of a 28-day cycle. If patient was receiving lenalidomide at a higher dose than 10 mg, then the dose of lenalidomide on this study will be adjusted to 10 mg daily on days 1-28 of a 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Ixazomib
FDA approved

Find a Location

Who is running the clinical trial?

OncotherapeuticsLead Sponsor
22 Previous Clinical Trials
924 Total Patients Enrolled
21 Trials studying Multiple Myeloma
901 Patients Enrolled for Multiple Myeloma
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,243 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,214 Patients Enrolled for Multiple Myeloma
James R. Berenson M Inc., MDPrincipal InvestigatorOncotherapeutics

Media Library

Lenalidomide Clinical Trial Eligibility Overview. Trial Name: NCT03733691 — Phase 2
Multiple Myeloma Research Study Groups: Ixazomib + Lenalidomide, Ixazomib Only
Multiple Myeloma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT03733691 — Phase 2
Lenalidomide 2023 Treatment Timeline for Medical Study. Trial Name: NCT03733691 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities available for prospective participants in this trial?

"Per the clinicaltrials.gov listing, this medical experiment is currently seeking applicants. The details of which were first published on March 1st 2019 and most recently revised October 23rd 2020."

Answered by AI

How many individuals is this investigation enrolling in total?

"Affirmative. According to clinicaltrials.gov, this investigation is still recruiting participants with the initial posting on March 1st 2019 and lastly updated October 23rd 2020. A total of fifty two volunteers are needed from a single medical centre for the trial's progression."

Answered by AI

What are the eligibility requirements for participation in this clinical experiment?

"Eligible participants of this medical trial must have neoplasms, plasma cell and be between the ages 18 to 100. There are currently 52 spots open for potential patients."

Answered by AI

Are there any age restrictions for participating in this experiment?

"This trial necessitates participants to be between 18 and 100 years old. For individuals younger than 18, there are 48 studies available while those above 65 have 1103 options."

Answered by AI

What disorders has Ixazomib been demonstrated to ameliorate?

"Ixazomib is mainly used to treat multiple myeloma, but it has also been administered in cases of relapsed and/or refractory lymphoma, chronic lymphocytic leukemia with at least two prior systemic chemotherapy regimens."

Answered by AI

Has Ixazomib been studied in other scientific investigations?

"Currently, there are 316 studies actively looking into the effects of Ixazomib. Of them, 59 have entered Phase 3 and will soon be evaluated for efficacy. This research is predominantly conducted in Chicago but also includes 14301 additional locations around the world."

Answered by AI

Has the FDA validated the use of Ixazomib?

"Due to the phase 2 status of this clinical trial, there is evidence indicating Ixazomib's safety but no proof that it works; thus giving it a rating of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ph 2 Maintenance Trial: Ixazomib vs Ixazomib-Lenalidomide for MM Patients
2019. "Ph 2 Maintenance Trial: Ixazomib vs Ixazomib-Lenalidomide for MM Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03733691.
~3 spots leftby Apr 2025
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