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Proteasome Inhibitor
Daratumumab-Based Regimens for Multiple Myeloma (DeRIVE Trial)
Phase 2
Waitlist Available
Led By Ajay Nooka, MD, MPH
Research Sponsored by Emory University
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 (PS) 0-1
Male patients, even if surgically sterilized, must agree to specified contraception methods
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years after study start
Awards & highlights
DeRIVE Trial Summary
This trial is testing daratumumab, ixazomib, dexamethasone, and bortezomib as a possible treatment for newly diagnosed multiple myeloma.
Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who are in good physical condition (ECOG PS 0-1) and have measurable disease. They can't have had certain other conditions or treatments, must agree to contraception if applicable, and be willing to follow the study rules. Pregnant women, those with allergies to study drugs, or patients treated previously with similar drugs are excluded.Check my eligibility
What is being tested?
The trial is testing a combination of daratumumab, ixazomib, and dexamethasone against the same combo plus bortezomib in treating new multiple myeloma cases. It aims to see which regimen is more effective at stopping cancer growth by comparing these two treatment groups.See study design
What are the potential side effects?
Possible side effects include immune system reactions like infusion-related symptoms, blood cell count changes leading to increased infection risk or bleeding problems, potential nerve damage causing numbness or pain, digestive issues such as nausea or constipation, and fatigue.
DeRIVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I agree to use contraception as required.
Select...
I have multiple myeloma with specific signs as per IMWG 2014.
DeRIVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years after study start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years after study start
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
≥ Very good partial response (VGPR) response rate
Secondary outcome measures
Best response on study
Duration of response (DOR)
Minimal residual disease (MRD)
+4 moreSide effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613460%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Pain in extremity
14%
Lymphopenia
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Musculoskeletal chest pain
10%
Muscle spasms
9%
Urinary tract infection
9%
Bone pain
9%
Leukopenia
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Alanine aminotransferase increased
8%
Abdominal pain upper
8%
Weight decreased
8%
Muscle Spasms
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Aspartate aminotransferase increased
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Abdominal pain
6%
Nasal congestion
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Humerus fracture
1%
Pneumonia cytomegaloviral
1%
Rib fracture
1%
Squamous cell carcinoma of skin
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Febrile neutropenia
1%
Pleural effusion
1%
Acute coronary syndrome
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Femur fracture
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Respiratory failure
1%
Bronchitis chronic
1%
Gastroenteritis
1%
Pathological fracture
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
DeRIVE Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (DVd, DId)Experimental Treatment4 Interventions
INDUCTION CYCLES 1-3: Patients receive dexamethasone IV and PO on days 1, 8, and 15, daratumumab IV on days 1, 8, and 15, and bortezomib subcutaneously (SC) on days 1, 4, 8, and 11. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity.
INDUCTION CYCLES 4-8: Patients receive dexamethasone IV and PO on days 1, 8, 15, and 22, daratumumab IV on days 1 and 15, and ixazomib PO on days 1, 8, and 15. Treatment repeats every 28 days for 5 cycles in the absence of disease progression or unacceptable toxicity. Eligible patients then undergo stem cell transplant per standard of care. Patients who have at least stable disease after induction and patients who have undergone transplant continue to Maintenance.
MAINTENANCE: Patients receive dexamethasone IV on day 1, daratumumab IV on day 1, and ixazomib PO on days 1, 8, and 15. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (DId)Experimental Treatment3 Interventions
INDUCTION: Patients receive dexamethasone IV and PO on days 1, 8, 15, and 22, daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2 and on days 1 and 15 of cycles 3-8, and ixazomib PO on days 1, 8, and 15. Treatment repeats every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Eligible patients then undergo stem cell transplant per standard of care. Patients who have at least stable disease after induction and patients who have undergone transplant continue to Maintenance.
MAINTENANCE: Patients receive dexamethasone IV and PO on days 1, 8, 15, and 22, daratumumab IV on day 1, and ixazomib PO on days 1, 8, and 15. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Ixazomib
2017
Completed Phase 4
~3370
Bortezomib
2005
Completed Phase 2
~1140
Daratumumab
2014
Completed Phase 3
~1860
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,524 Total Patients Enrolled
25 Trials studying Multiple Myeloma
1,929 Patients Enrolled for Multiple Myeloma
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,213 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,184 Patients Enrolled for Multiple Myeloma
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,539 Total Patients Enrolled
16 Trials studying Multiple Myeloma
887 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong CYP3A inducers or St. John's wort recently.I agree to use contraception as required.I am allergic or react badly to dexamethasone, boron, mannitol, or similar drugs.I have been treated with anti-CD38 therapy before.I am fully active or restricted in physically strenuous activity but can do light work.You have a certain level of M-protein in your blood or urine that can be measured.I have taken more than 160 mg of steroids or more than 2 doses of bortezomib.I have not had radiotherapy in the days leading up to joining.I don't have any serious illness that could stop me from completing the treatment.I have been diagnosed with a specific blood or bone marrow condition.I haven't had or been treated for another cancer within the last 2 years.I agree not to donate blood during and for 8 weeks after my treatment.My cancer has spread to my brain or spinal cord.I am a woman who is either postmenopausal, surgically sterile, or capable of bearing children.I have multiple myeloma with specific signs as per IMWG 2014.I do not have serious heart, stroke, COPD, or uncontrolled asthma issues.I have received up to 160 mg of steroids for treatment.I am currently taking certain medications along with my treatment.I have been treated with or been part of a study involving ixazomib.You have tested positive for certain infectious diseases.I have nerve, kidney, blood, liver, or heart issues.I had major surgery less than 4 weeks ago or am still dealing with its side effects.I am currently pregnant or breastfeeding.I have received up to 2 doses of bortezomib to stabilize my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (DId)
- Group 2: Arm II (DVd, DId)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what conditions are treatment regimens featuring Daratumumab commonly prescribed?
"Daratumumab has been clinically demonstrated to successfully treat ophthalmia, sympathetic conditions, branch retinal vein occlusions, and macular edema."
Answered by AI
Has Daratumumab been officially sanctioned by the FDA?
"The safety of Daratumumab has been assessed as a 2, since the trial is currently at Phase 2 and there is data indicating its security but no evidence yet that it achieves desired results."
Answered by AI
Could you provide a summary of the prior research performed regarding Daratumumab?
"At the present moment, there are 666 clinical trials dedicated to exploring Daratumumab. Of these studies, 153 have reached Phase 3 in their research while 21944 sites worldwide are running such experiments. Specifically, many of these locations lie within Mishawaka, Indiana."
Answered by AI
How many participants is the trial looking to recruit?
"Affirmative. The study, first published on July 3rd 2019 and recently updated in December 2021, is actively recruiting according to clinicaltrials.gov. 76 participants need to be enrolled at 1 medical centre."
Answered by AI
Is there still room for volunteers in this experiment?
"From clinicaltrials.gov, it is evident that this trial has reached its recruitment phase. Having been initially posted on July 3rd 2019, the data was last amended at the end of December 2021."
Answered by AI
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