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Monoclonal Antibodies

Lenalidomide & Dexamethasone for Multiple Myeloma

Phase 3

Recruiting

Research Sponsored by Canadian Cancer Trials Group

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 8.1 years

Awards & highlights

Study Summary

This trial aims to determine if stopping the medication daratumumab after about a year and a half of treatment is as effective as continuously giving it with lenalidomide and dexamethas

Who is the study for?

This trial is for older adults who can't have a bone marrow transplant and are newly diagnosed with multiple myeloma. They should have measurable disease, been treated with daratumumab-lenalidomide-dexamethasone for 18-20 cycles, and shown some response to treatment. Participants must be able to complete questionnaires in certain languages, follow the study's procedures, use effective birth control if needed, and start the treatment within two days of joining.Check my eligibility

What is being tested?

The study tests whether giving daratumumab for a fixed period (about 1.5 years) combined with lenalidomide and dexamethasone is as effective as continuing it non-stop in treating multiple myeloma in patients who aren't eligible for a bone marrow transplant.See study design

What are the potential side effects?

Daratumumab may cause infusion reactions like fever or chills; lenalidomide can lead to blood clots or fatigue; dexamethasone might result in increased appetite or mood changes. Side effects vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8.1 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8.1 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8.1 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

Progression-Free Survival

Secondary outcome measures

Health Economic Analyses Utilizing EQ-5D-5L

Incidence of Treatment-Related Grade 3-5 Adverse Events and all infections based on CTCAE 5.0

Overall Survival

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lenalidomide & DexamethasoneExperimental Treatment2 Interventions

Group II: Daratumumab, Lenalidomide & DexamethasoneActive Control3 Interventions

Standard of Care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

Lenalidomide

2005

Completed Phase 3

~1480

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,452,955 Total Patients Enrolled

1 Trials studying Multiple Myeloma

92 Patients Enrolled for Multiple Myeloma

Myeloma CanadaUNKNOWN

Canadian Cancer Trials GroupLead Sponsor

126 Previous Clinical Trials

67,483 Total Patients Enrolled

2 Trials studying Multiple Myeloma

796 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

What is the current number of individuals being recruited for participation in this clinical research study?

"Affirmative. The information on clinicaltrials.gov indicates that this research is actively enrolling volunteers. It was initially posted on April 10, 2024, and last revised on April 11, 2024. The study aims to recruit a total of 559 participants from one designated site."

Answered by AI

Has Lenalidomide & Dexamethasone been granted approval by the FDA?

"Based on the comprehensive evaluation by our team at Power, we have rated the safety profile of Lenalidomide & Dexamethasone as a 3. This rating is attributed to the advanced stage of this trial (Phase 3), indicating substantial evidence supporting both effectiveness and safety through multiple data assessments."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"Indeed, as per clinicaltrials.gov data, this research study is actively seeking suitable participants. The trial information was initially uploaded on April 10th, 2024 and last revised on April 11th, 2024. It aims to recruit a total of 559 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma

2024. "Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06182774.