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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
Age >18 years with no upper age limit
No prior MM-directed therapy except for dexamethasone (up to 160 mg) and/or bortezomib (up to 5.2 mg/m2) and/or cyclophosphamide up to 1000 mg/m2 administered for management of acute manifestations of MM (hypercalcemia, renal impairment, pain) for no longer than 4 weeks prior to enrollment. If subject received any prior therapy, pretreatment parameters necessary for disease characterization and response assessment must be available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 years
Awards & highlights

MASTER Trial Summary

This trial is testing a new treatment regimen for MM that may be more effective than current treatments.

Eligible Conditions
  • Multiple Myeloma

MASTER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must be at least 18 years old with no maximum age limit.
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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.
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You are expected to live for at least 12 months.
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You are able to carry out daily activities without any major issues.
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You have been recently diagnosed with multiple myeloma and need to start treatment.

MASTER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 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
Percentage of Patients With MRD(-) Remissions at the Completion of Consolidation Therapy
Secondary outcome measures
Overall Survival
Percentage of Patients Achieving Complete Remission Following Complete Therapy
Percentage of Patients That Convert From MRD(-) to MRD(+) Following Treatment Discontinuation
+4 more

Side effects data

From 2023 Phase 2 trial • 123 Patients • NCT03224507
56%
fatigue
55%
Bone pain
41%
maculopapular rash
41%
Neutropenia
40%
Nausea
39%
constipation
37%
Upper respiratory tract infection
35%
diarrhea
28%
insomnia
28%
Lymphopenia
28%
infusion-related reaction
28%
dyspnea
27%
cough
26%
hypertension
19%
Anemia
7%
Lung Infection
2%
Thomboembolism
2%
sudden death
1%
Viral pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
KRdD Followed by Auto-HCT
KRdD Only

MASTER 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?

University of Alabama at BirminghamLead Sponsor
1,565 Previous Clinical Trials
2,268,235 Total Patients Enrolled
10 Trials studying Multiple Myeloma
6,912 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,355 Previous Clinical Trials
1,383,948 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,623 Patients Enrolled for Multiple Myeloma
Janssen Scientific Affairs, LLCIndustry Sponsor
157 Previous Clinical Trials
579,549 Total Patients Enrolled
23 Trials studying Multiple Myeloma
1,973 Patients Enrolled for Multiple Myeloma

Media Library

KRdD (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03224507 — Phase 2
Multiple Myeloma Research Study Groups: KRdD followed by auto-HCT, KRdD only
Multiple Myeloma Clinical Trial 2023: KRdD Highlights & Side Effects. Trial Name: NCT03224507 — Phase 2
KRdD (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03224507 — Phase 2

Frequently Asked Questions

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

How widely is the survey being conducted across North America?

"This research study is recruiting patients from 4 medical facilities, such as Oregon Health and Science University in Portland, University of Wisconsin's School of Medicine and Public Health in Madison, Vanderbilt Ingram Cancer Center in Nashville, plus four additional sites."

Answered by AI

What is the current enrolment limit for this research project?

"At this time, no new patients are being recruited for the study that was first advertised on March 14th 2018 and last edited September 12th 2022. However, if you're looking for alternative studies, 807 trials related to multiple myeloma and 751 investigations concerning KRdD plus auto-HCT are actively seeking participants."

Answered by AI

Could you provide a synopsis of findings from prior research regarding KRdD and subsequent auto-HCT?

"The KRdD procedure followed by an autologous hematopoietic stem cell transplantation was first trialled in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since then, 1391 trials have been completed, with 751 presently active clinical studies - many of which are conducted out of Portland, Oregon."

Answered by AI

What type of ailment is the KRdD and auto-HCT treatment regimen typically used to target?

"Ophthalmologic sympathetic ophthalmia typically calls for KRdD and auto-HCT as the treatment of choice. Additionally, this twofold approach has been shown to be helpful in managing a range of other health issues such as post-chemotherapy complications, branch retinal vein occlusion, and macular edema."

Answered by AI

Has the Food and Drug Administration greenlighted KRdD preceding autologous hematopoietic cell transplantation?

"After carefully assessing the data available, our team at Power has assigned KRdD followed by auto-HCT a rating of 2 on the safety scale. Since this is only in Phase 2, there are limited confirmations of its efficacy and some evidence to suggest it may be safe."

Answered by AI

Is this experiment presently procuring participants?

"This research endeavour has closed its doors to new patients, as the last edit date was September 12th 2022. However, if you are looking for other trials that might suit your needs, there are currently 807 clinical studies inviting people with multiple myeloma and 751 similar efforts recruiting those suffering from KRdD in combination with auto-HCT."

Answered by AI
~18 spots leftby Mar 2025