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Proteasome Inhibitor
Sequential Therapy for Multiple Myeloma (MASTER-2 Trial)
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
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood test shows a significant difference in specific proteins.
Select...
I can take care of myself and perform daily activities.
Select...
I have been recently diagnosed with multiple myeloma and need to start treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Depth of response obtained with 6 cycles of Dara-VRd
Sustained MRD negativity
Secondary study objectives
Neoplasm, Residual
Overall Survival
Progression-free survival
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
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,621 Previous Clinical Trials
2,290,678 Total Patients Enrolled
11 Trials studying Multiple Myeloma
7,185 Patients Enrolled for Multiple Myeloma
Janssen Scientific Affairs, LLCIndustry Sponsor
161 Previous Clinical Trials
579,641 Total Patients Enrolled
23 Trials studying Multiple Myeloma
1,740 Patients Enrolled for Multiple Myeloma
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