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Monoclonal Antibodies
DaraVRD for Multiple Myeloma
Phase 2
Recruiting
Led By Susan Bal, MD
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 with a diagnosis of newly diagnosed multiple myeloma with indication for initiation of therapy with Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 7 years
Awards & highlights
Study Summary
This trial is testing whether using a next generation sequencing test to check for minimal residual disease can help doctors decide when to do an autologous hematopoietic stem cell transplant for people with newly diagnosed multiple myeloma.
Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who haven't had much prior treatment. They must be expected to live at least a year, have good organ function, and agree to use contraception. It's important they can follow the study rules and are fit enough for stem cell transplant. At least 30% of participants will be ethnic/racial minorities.Check my eligibility
What is being tested?
The MILESTONE trial is testing if using next-generation sequencing to check for minimal residual disease can help decide whether patients with new multiple myeloma can wait before having a stem cell transplant. The intervention being tested is DaraVRD.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation, such as infusion-related symptoms, liver issues reflected by increased enzymes or bilirubin levels, kidney problems shown by reduced clearance rates, blood disorders like anemia or clotting issues, and potential harm to unborn babies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18, diagnosed with multiple myeloma, and need to start treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who are able to attain MRD<10-5 by next generation sequencing after 6 cycles of Dara-VRD and defer AHCT.
Secondary outcome measures
Number of patients who was MRD>10-5 that undergo AHCT and attain MRD<10-5.
Overall survival
Progression free survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Induction - Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DaraVRD)Experimental Treatment1 Intervention
Quadruplet therapy with DaraVRD in the treatment of newly diagnosed myeloma
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,462 Total Patients Enrolled
10 Trials studying Multiple Myeloma
7,015 Patients Enrolled for Multiple Myeloma
Susan Bal, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe nerve pain or damage.At least 30% of people from different ethnic or racial backgrounds will be included in the study. If needed, the enrollment of people from other backgrounds may be paused to make sure that at least 30% of ethnic minorities are included.I have had a stroke before or a temporary blockage of blood flow to my brain in the last year.I agree to use birth control and undergo pregnancy tests if required.I haven't had major surgery, radiotherapy, or needed treatment for an infection in the last 14 days.I have been diagnosed with POEMS syndrome or Waldenstrom's macroglobulinemia.My HIV or hepatitis is under control with an undetectable viral load.I've only had short-term treatment for my multiple myeloma symptoms.You have a certain amount of abnormal proteins in your blood or urine.My liver and kidney functions meet the required levels for treatment.I haven't had a recent heart attack and my heart condition is stable.I am eligible for a stem cell transplant using my own cells, as per my doctor's assessment.I haven't had cancer in the last 3 years, except for certain skin, thyroid, cervix, breast, prostate cancers, or cancers considered cured or unlikely to impact survival.I am over 18, diagnosed with multiple myeloma, and need to start treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Induction - Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DaraVRD)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have any other exploratory trials been conducted with DaraVRD?
"Currently, there are 780 trials of DaraVRD in progress with 170 entering the third phase. While Joliet, Illinois holds a majority of these clinical studies, there exists 26738 locations around the world involved in them."
Answered by AI
Are there still opportunities for individuals to become participants in this research?
"The clinical trial, first posted on September 22nd 2021 and most recently modified on October 31st 2022, is presently recruiting participants as indicated by clinicaltrials.gov."
Answered by AI
How many participants are enrolled in this experiment?
"Affirmative. Clinicaltrials.gov lists this trial as currently enrolling, having initially been posted on September 22nd 2021 and was last revised October 31st 2022. The goal is to recruit 20 individuals from a single site."
Answered by AI
What conditions have been found to respond positively to treatment with DaraVRD?
"DaraVRD is a viable form of treatment for ophthalmia, sympathetic disorders, diseases that have not responded to two prior chemotherapeutic regimens, and branch retinal vein occlusions."
Answered by AI
Has the Food and Drug Administration given official clearance for DaraVRD?
"Despite not having any evidence of efficacy yet, we have assigned a score of 2 to DaraVRD's safety due to the existing data backing its security."
Answered by AI
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