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Proteasome Inhibitor

Arm C for Multiple Myeloma (MASTER-2 Trial)

Q: Is enrollment still open for this research endeavor?

Affirmative. Evident from clinicaltrials.gov, this investigation is presently searching for individuals to take part in the trial. It was first posted on December 13th 2023 and has recently been updated with 300 participants needed at 1 site of research.

Q: What potential risks are associated with Arm A of the trial?

Our team has classified the safety of Arm A at a 2, given that this is only a Phase 2 clinical trial and thus there are data in support of its safeness but no evidence to affirm its efficacy.

Q: How many participants have the capacity to join this research project?

Affirmative. The information on clinicaltrials.gov states that this study is seeking participants as of now. It was initially announced on December 13th 2023 and the most recent edit to it occurred at the same time, looking for around 300 patients from a single medical facility.

Phase 2

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Difference between affected and unaffected free light chain ≥10 mg/dL with abnormal kappa to lambda ratio.

ECOG performance status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

MASTER-2 Trial Summary

This trial studies how well treatment works in reducing multiple myeloma cells to <1 out of 100k in bone marrow after 6 cycles of treatment & whether more patients can be and stay MRD "negative" with 3 additional cycles.

Who is the study for?

This trial is for adults over 18 with newly diagnosed multiple myeloma needing treatment. They should be fairly active (ECOG 0-2) and can have had limited prior treatments like dexamethasone or bortezomib. Their blood work must show certain levels of monoclonal protein, and they need specific lab values for hemoglobin and platelets.Check my eligibility

What is being tested?

The study tests if patients who reach very low levels of cancer cells after 6 cycles of therapy can maintain this with more treatment instead of a stem cell transplant. It also checks if adding teclistamab to the transplant process helps those not yet at low cancer cell levels achieve it better than standard drugs plus daratumumab.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation, such as infusion reactions, bone marrow suppression leading to anemia or infection risk increase, fatigue, digestive issues, and potential impact on organ function.

MASTER-2 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My blood test shows a significant difference in specific proteins.

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I can take care of myself and perform daily activities.

Select...

I have been recently diagnosed with multiple myeloma and need to start treatment.

MASTER-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Depth of response obtained with 6 cycles of Dara-VRd

Sustained MRD negativity

Secondary outcome measures

Neoplasm, Residual

Overall Survival

Progression-free survival

MASTER-2 Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Arm MExperimental Treatment1 Intervention

Induction - 6 cycles of Dara-VRd in all participants

Group II: Arm CExperimental Treatment1 Intervention

AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance in MRD positive patients

Group III: Arm AExperimental Treatment1 Intervention

3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance in MRD negative patients

Group IV: Arm BActive Control1 Intervention

AHCT intensification followed by 13 cycles of Dara-R maintenance in MRD negative patients

Group V: Arm DActive Control1 Intervention

AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance in MRD positive patients

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,362 Total Patients Enrolled

10 Trials studying Multiple Myeloma

6,735 Patients Enrolled for Multiple Myeloma

Janssen Scientific Affairs, LLCIndustry Sponsor

159 Previous Clinical Trials

580,218 Total Patients Enrolled

23 Trials studying Multiple Myeloma

1,796 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.

Is enrollment still open for this research endeavor?

"Affirmative. Evident from clinicaltrials.gov, this investigation is presently searching for individuals to take part in the trial. It was first posted on December 13th 2023 and has recently been updated with 300 participants needed at 1 site of research."

Answered by AI

What potential risks are associated with Arm A of the trial?

"Our team has classified the safety of Arm A at a 2, given that this is only a Phase 2 clinical trial and thus there are data in support of its safeness but no evidence to affirm its efficacy."

Answered by AI

How many participants have the capacity to join this research project?

"Affirmative. The information on clinicaltrials.gov states that this study is seeking participants as of now. It was initially announced on December 13th 2023 and the most recent edit to it occurred at the same time, looking for around 300 patients from a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sequential Therapy in Multiple Myeloma Guided by MRD Assessments

Luciano Jose Costa, MD 2023. "Sequential Therapy in Multiple Myeloma Guided by MRD Assessments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05231629.

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