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Proteasome Inhibitor
Daratumumab + VRd for Multiple Myeloma
Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Diagnosis of multiple myeloma as documented per International Myeloma Working Group (IMWG) criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until the participant's death from any cause (up to approximately 6 years, or 9 years if the adaptive approach is decided at the interim)
Awards & highlights
Study Summary
This trial is testing whether adding daratumumab to the standard treatment for multiple myeloma will improve the rate of patients achieving undetectable levels of the disease.
Who is the study for?
This trial is for adults with untreated multiple myeloma who don't plan to have a stem cell transplant right away. They must have measurable disease, be able to perform daily activities (ECOG score 0-2), and women of childbearing age need two negative pregnancy tests before dosing. People can't join if they've had other cancer treatments or certain health conditions like severe neuropathy.Check my eligibility
What is being tested?
The study is testing whether adding Daratumumab to the combination of Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) improves outcomes compared to just VRd in treating multiple myeloma. The main goal is seeing if this mix reduces the number of remaining cancer cells better than the standard combo.See study design
What are the potential side effects?
Possible side effects include immune system reactions, nerve damage symptoms like numbness or pain, blood clots, low blood counts leading to increased infection risk or bleeding problems, fatigue, digestive issues such as nausea or constipation, and potential harm to an unborn baby.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have been diagnosed with multiple myeloma according to IMWG standards.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until the participant's death from any cause (up to approximately 6 years, or 9 years if the adaptive approach is decided at the interim)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until the participant's death from any cause (up to approximately 6 years, or 9 years if the adaptive approach is decided at the interim)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with Negative Minimal Residual Disease (MRD) Status
Secondary outcome measures
Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Multiple Myeloma 20-item (EORTC QLQ-MY20)
+14 moreSide effects data
From 2008 Phase 2 trial • 20 Patients • NCT00006184100%
Injection site reaction
40%
Fatigue (asthenia, lethargy, malaise)
30%
Pruritus
30%
Platelets
30%
Chest pain (non-cardiac and non-pleuritic)
30%
Bone pain
30%
Headache
30%
Myalgia (muscle ache)
30%
SGPT (ALT)
30%
Abdominal pain or cramping
20%
Alkaline phosphatase
20%
Hypokalemia
20%
Dizziness/lightheadedness
20%
Arthralgia (joint pain)
20%
Hypomagnesemia
20%
Pain - Other
20%
Rash/desquamation
20%
Rigors/chills
20%
SGOT (AST)
10%
Hypoalbuminemia
10%
Hypocalcemia
10%
Hot flashes/flushes
10%
Hypophosphatemia
10%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
10%
Lymphopenia
10%
Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis
10%
Dry skin
10%
Constipation
10%
Hypotension
10%
Joint, muscle, or bone (osseous)- Other (Calf cramping)
10%
Hypercalcemia
10%
Skin-Other (Drug reaction face, hands, neck)
10%
Hematologic-Other (Splenomegaly in donor-resolved)
10%
Dyspnea (shortness of breath)
10%
Rash/desquamation for BMT
10%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donor - Vaccination Generation Group
Recipient - Chemotherapy Group
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Daratumumab + VRd (D-VRd) and DRdExperimental Treatment4 Interventions
Participants will receive daratumumab 1800 mg as SC injection once every week for Cycles 1 to 2, then every 3 weeks for Cycles 3 through 8 and every 4 weeks for Cycle 9 and beyond; bortezomib 1.3 mg/m^2 as SC injection twice weekly on Days 1, 4, 8, 11 for Cycles 1 through 8 (each cycle is of 21 days); lenalidomide 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9; dexamethasone 20 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, 12 for Cycles 1 through 8 and 40 mg on Days 1,8, 15 and 22 during Cycle 9 and beyond followed by daratumumab-lenalidomide-dexamethasone (DRd) until disease progression or unacceptable toxicity.
Group II: Bortezomib + Lenalidomide + Dexamethasone (VRd) and RdActive Control3 Interventions
Participants will receive bortezomib 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection twice weekly on Days 1, 4, 8, 11 for Cycles 1 through 8 (each cycle is of 21 days); lenalidomide 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9 (cycle of 28 days); dexamethasone 20 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, 12 for Cycles 1 through 8 and 40 mg on Days 1,8, 15 and 22 during Cycle 9 and beyond (each cycle is of 28 days) followed by lenalidomide-dexamethasone (Rd) until disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1860
Bortezomib
2005
Completed Phase 2
~1140
Lenalidomide
2005
Completed Phase 3
~1480
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,913 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,022 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,510 Total Patients Enrolled
49 Trials studying Multiple Myeloma
13,989 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe nerve pain or damage.I have only used a short course of corticosteroids for my multiple myeloma.I haven't had cancer, except for certain skin cancers or early-stage cervical or breast cancer, in the last 5 years.I have not had focused radiation therapy in the last 14 days, except for pain relief.You must have a way for doctors to measure your disease using tests from a central laboratory.I can take care of myself and am up and about more than half of my waking hours.You have a score of 2 or higher on the Myeloma Geriatric Assessment, which measures how frail or weak you are.I have been diagnosed with multiple myeloma according to IMWG standards.
Research Study Groups:
This trial has the following groups:- Group 1: Bortezomib + Lenalidomide + Dexamethasone (VRd) and Rd
- Group 2: Daratumumab + VRd (D-VRd) and DRd
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Are new patients being accepted into the program at this time?
"The clinical trial in question is not currently enrolling patients, as indicated by the data on clinicaltrials.gov. This particular study was posted on November 6th, 2018 and updated September 8th, 2022; however, there are many other trials (over 1600) that are actively recruiting participants."
Answered by AI
Is Bortezomib a new or experimental medication?
"Bortezomib's first clinical trial was completed in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. As of now, a total of 1632 trials have been completed with 814 more currently active. Many of these ongoing studies are based out of Boston, Massachusetts."
Answered by AI
How many people are signing up to participate in this clinical trial?
"This trial is not recruiting at the moment. The study's first posting was on November 6th, 2018 with the latest update being September 8th, 2022. However, there are many other trials seeking patients with either multiple myeloma or Bortezomib that might be a better fit – 826 and 814 respectively."
Answered by AI
In how many different medical settings is this research being conducted today?
"There are a total of 28 hospitals that are participating in this clinical trial. Some notable locations include Boston University Medical Center, Tufts Medical Center, and Roswell Park Cancer Institute."
Answered by AI
Is Bortezomib known to cause any serious health complications?
"There is some evidence for efficacy and multiple rounds of data supporting safety, so the Power team rates Bortezomib's safety as a 3."
Answered by AI
What are some of the most common reasons why doctors prescribe Bortezomib?
"Bortezomib is a common treatment for ophthalmia, sympathetic. It can also help patients who have undergone at least two prior systemic chemotherapy regimens, branch retinal vein occlusion, and macular edema."
Answered by AI
Who else is applying?
What site did they apply to?
Lakeridge Health Oshawa
What portion of applicants met pre-screening criteria?
Met criteria
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