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Maintenance Therapy Discontinuation for Multiple Myeloma (HEME-20 Trial)

Phase 1

Recruiting

Led By Karen Sweiss, PhamD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Revised International Staging System (R-ISS) I,2 or 3

Patients with multiple myeloma as defined by IMWG

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

HEME-20 Trial Summary

This trial is testing whether it's safe to stop maintenance therapy for multiple myeloma patients who have had a stem cell transplant and are in remission.

Who is the study for?

This trial is for Multiple Myeloma patients who are MRD-negative after a stem cell transplant and have been on maintenance therapy for at least 2 years. They should be in good physical condition (ECOG ≤2) and have had a very good partial response or complete remission. It's not open to those with certain other plasma disorders, prior organ transplants, or those on immunosuppressive therapy.Check my eligibility

What is being tested?

The FREEDMM Trial is testing the safety of stopping standard maintenance drugs used after an autologous stem cell transplant in patients with no minimal residual disease. The goal is to see if halting treatment affects the risk of their cancer progressing.See study design

What are the potential side effects?

Since this trial involves discontinuing maintenance medications rather than administering new ones, side effects would relate to potential multiple myeloma progression rather than drug-related adverse reactions.

HEME-20 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My multiple myeloma is classified as stage I, II, or III.

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I have been diagnosed with multiple myeloma according to IMWG criteria.

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I have completed at least 2 years of maintenance therapy after my stem cell transplant.

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My disease is responding well to treatment.

HEME-20 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Compare health-related quality of life (HRQoL) between MM patients stopping versus continuing maintenance therapy

Cell Count

Number of participants that have a sustained MRD-negative VGPR or CR measured by a bone marrow biopsy

+3 more

HEME-20 Trial Design

2Treatment groups

Experimental Treatment

Group I: Bone marrow MRD-positive VGPR or CRExperimental Treatment1 Intervention

Continue maintenance therapy as per SOC

Group II: Bone marrow MRD-negative VGPR or CRExperimental Treatment1 Intervention

Discontinue maintenance therapy after at least three years

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

609 Previous Clinical Trials

1,559,259 Total Patients Enrolled

4 Trials studying Multiple Myeloma

165 Patients Enrolled for Multiple Myeloma

Karen Sweiss, PhamDPrincipal InvestigatorUniversity of Illinois at Chicago

Media Library

Discontinue maintenance therapy SOC (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT05192122 — Phase 1

Multiple Myeloma Research Study Groups: Bone marrow MRD-positive VGPR or CR, Bone marrow MRD-negative VGPR or CR

Multiple Myeloma Clinical Trial 2023: Discontinue maintenance therapy SOC Highlights & Side Effects. Trial Name: NCT05192122 — Phase 1

Discontinue maintenance therapy SOC (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05192122 — Phase 1

Frequently Asked Questions

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

Has this treatment earned the stamp of approval from the FDA?

"Our team at Power cautiously rated the safety of this treatment as a 1 because it is currently in Phase 1 trials, which implies there are limited findings to support its efficacy and safety."

Answered by AI

Are there vacancies for participants in this scientific research endeavor?

"According to the clinicaltrials.gov database, recruitment for this medical trial is still ongoing. This research was initially posted on December 31st 2021 and recently updated on October 3rd 2022."

Answered by AI

What is the sample size of individuals being observed in this clinical experiment?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical experiment, which was first advertised on December 31st 2021, is currently recruiting participants. Approximately 50 patients must be enrolled from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial) for Minimal Residual Disease (MRD

Karen Sweiss 2021. "Free From Maintenance Drug Therapy in Multiple Myeloma (The FREEDMM Trial) for Minimal Residual Disease (MRD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05192122.