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Monoclonal Antibodies
Sequential Therapy for Multiple Myeloma (MASTER Trial)
Phase 2
Waitlist Available
Led By Luciano J Costa, MD, PhD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial uses a combination of four drugs and a stem cell procedure to treat newly diagnosed multiple myeloma. The drugs kill cancer cells and stop their growth, while the stem cell procedure helps recovery. This approach aims to achieve deep remission without relapse.
Eligible Conditions
- Multiple Myeloma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Patients With MRD(-) Remissions at the Completion of Consolidation Therapy
Secondary study objectives
Overall Survival
Percentage of Patients Achieving Complete Remission Following Complete Therapy
Percentage of Patients That Convert From MRD(-) to MRD(+) Following Treatment Discontinuation
+4 moreSide effects data
From 2023 Phase 2 trial • 123 Patients • NCT0322450756%
fatigue
55%
Bone pain
41%
Neutropenia
41%
maculopapular rash
40%
Nausea
39%
constipation
37%
Upper respiratory tract infection
35%
diarrhea
28%
Lymphopenia
28%
insomnia
28%
infusion-related reaction
28%
dyspnea
27%
cough
26%
hypertension
19%
Anemia
7%
Lung Infection
2%
sudden death
2%
Thomboembolism
1%
Viral pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
KRdD Followed by Auto-HCT
KRdD Only
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: KRdD onlyExperimental Treatment1 Intervention
Cycle 1-Dexamethasone 40mg orally days 1/8/15/22; Lenalidomide 25mg orally days 1-21; Carfilzomib 20mg/m2 days 8/9 then @ 36mg/m2 venous days 15/16; Daratumumab 16mg/kg venous days 1/8/15/22. Cycle 2 the same except Carfilzomib 36mg/m2 venous days 1/2/8/9/15/16. Cycles 3,4 the same but no Daratumumab Day 22. Dosage adjusted for last tolerated dose (LTD). Following induction therapy, Following induction therapy, patients will receive up to three 4-cycle blocks of KRd-Dara consolidation (consolidations 1, 2 and 3). Minimum residual disease (MRD) checked after each phase. Patients with confirmed MRD(-) at or after consolidation 1 will not undergo maintenance and will be actively monitored for resurgence of MRD or clinical relapse. After consolidation if MRD+ patients will undergo standard of care lenalidomide maintenance.
Group II: KRdD followed by auto-HCTExperimental Treatment1 Intervention
Cycle 1-Dexamethasone 40mg orally days 1/8/15/22; Lenalidomide 25mg orally days 1-21; Carfilzomib 20mg/m2 days 8/9 then 36mg/m2 venous days 15/16; Daratumumab 16mg/kg venous days 1/8/15/22 (KRd-Dara). Cycle 2 the same except Carfilzomib 36mg/m2 venous days 1/2/8/9/15/16. Cycles 3,4 the same but no Daratumumab Days 8 and 22. Dosage adjusted for last tolerated dose (LTD). Following induction therapy, auto-HCT is done (consolidation 1), then up to two 4-cycle blocks of KRd-Dara consolidation (consolidations 2 and 3). Minimum residual disease (MRD) checked after each phase. Patients with confirmed MRD(-) at or after consolidation 1 will not undergo maintenance and will be actively monitored for resurgence of MRD or clinical relapse. After consolidation if MRD+ patients will undergo standard of care lenalidomide maintenance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KRdD followed by auto-HCT
2018
Completed Phase 2
~130
KRdD only
2018
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Janssen Scientific Affairs, LLCIndustry Sponsor
164 Previous Clinical Trials
579,850 Total Patients Enrolled
24 Trials studying Multiple Myeloma
1,947 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,433 Previous Clinical Trials
1,395,019 Total Patients Enrolled
97 Trials studying Multiple Myeloma
20,642 Patients Enrolled for Multiple Myeloma
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,650 Total Patients Enrolled
11 Trials studying Multiple Myeloma
7,362 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to Captisol, which is a substance used to dissolve carfilzomib.You have had fluid drained from around your lungs or abdomen in the past 3 weeks.You must be at least 18 years old with no maximum age limit.You have been diagnosed with certain specific blood-related conditions.Your lung function is less than half of what is expected for someone your age and size.You haven't received any specific treatment for your condition, except for certain medications used to manage symptoms, for up to four weeks before joining the study. If you did receive treatment, we need to have certain test results to understand your condition.You have a certain amount of abnormal proteins in your blood or urine.You are expected to live for at least 12 months.You have had a heart attack or unstable angina in the last 4 months, or you have severe heart problems that are not well controlled.You are able to carry out daily activities without any major issues.You have been recently diagnosed with multiple myeloma and need to start treatment.You have HIV.You have an ongoing hepatitis B or C infection.Your liver is working well, with specific levels of ALT and bilirubin within a certain range.Your kidneys are working well, with a clearance of creatinine greater than 40 mL per minute, as measured by a test or calculated using a standard formula.You have had a stroke or mini-stroke (TIA) in the past year.You had cancer, except for certain types that were treated and are unlikely to affect your health during the study.You have severe nerve damage or moderate nerve damage with pain within the past 21 days.You cannot take Aspirin or Acyclovir because they cause a bad reaction or are not safe for you.
Research Study Groups:
This trial has the following groups:- Group 1: KRdD followed by auto-HCT
- Group 2: KRdD only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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