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Proteasome Inhibitor
Daratumumab-Based Therapy for Multiple Myeloma with Kidney Failure
Phase 2
Recruiting
Led By R. Donald Harvey, PharmD
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) 0-2
Creatinine clearance < 30 mL/min by Cockcroft-Gault (C-G), 24 hour urine collection or the Modification of Diet in Renal Disease (MDRD) methods
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is studying how well daratumumab-based therapy works in treating patients with newly diagnosed multiple myeloma with kidney failure. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Bortezomib is a drug that prevents myeloma cells from getting rid of their waste products, leading to being targeted for death. Dexamethasone is a steroid that is commonly used, either alone or in combination with other drugs, to treat multiple myeloma. Lenalidomide and thalidomide may stop the growth of multiple myeloma
Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma and kidney failure. They must have measurable disease, agree to not donate blood, use effective contraception, and have an ECOG performance status of 0-2. Creatinine clearance should be under 30 mL/min. Prior limited treatment with steroids or bortezomib is allowed.Check my eligibility
What is being tested?
The study tests a combination therapy including daratumumab (a monoclonal antibody), bortezomib (blocks waste disposal in cancer cells), dexamethasone (a steroid), and thalidomide or lenalidomide (block tumor growth). The goal is to see how well this regimen treats multiple myeloma in patients with kidney failure.See study design
What are the potential side effects?
Possible side effects include infusion reactions from daratumumab, nerve damage from bortezomib, mood swings or increased infection risk from dexamethasone, and birth defects if thalidomide or lenalidomide are taken during pregnancy.
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...
My kidney function is reduced with a creatinine clearance below 30 mL/min.
Select...
I have been diagnosed with multiple myeloma according to IMWG 2014 criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in creatinine clearance
Secondary outcome measures
Best overall response
Duration of response
Incidence of adverse events
+5 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%
Lymphopenia
14%
Pain in extremity
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%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Nasal congestion
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Abdominal pain
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%
Pneumonia cytomegaloviral
1%
Pleural effusion
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Febrile neutropenia
1%
Acute coronary syndrome
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Respiratory failure
1%
Bronchitis chronic
1%
Squamous cell carcinoma of skin
1%
Humerus fracture
1%
Gastroenteritis
1%
Pathological fracture
1%
Femur 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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (daratumumab-based treatment)Experimental Treatment5 Interventions
Patients receive daratumumab IV weekly of cycles 1-3 and on day 1 only of cycle 4, bortezomib SC on days 1, 4, 8, and 11, and dexamethasone IV or PO on days 1-4 of cycle 1 and on day 1 of cycles 2-4 and PO on days 8 and 15 of all cycles. Beginning cycle 2, patients may also receive lenalidomide PO daily on days 1-14 or thalidomide PO QD on days 1-21. Treatment repeats every 21 days for 4 cycles 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
Bortezomib
2005
Completed Phase 2
~1140
Daratumumab
2014
Completed Phase 3
~1860
Lenalidomide
2005
Completed Phase 3
~1480
Thalidomide
2001
Completed Phase 4
~3050
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,507 Total Patients Enrolled
25 Trials studying Multiple Myeloma
1,954 Patients Enrolled for Multiple Myeloma
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,493 Total Patients Enrolled
23 Trials studying Multiple Myeloma
2,071 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,856 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,106 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my brain or spinal cord.You are allergic to certain drugs.Your hemoglobin level is less than 7.0 grams per deciliter at the time of screening.I can take care of myself and am up and about more than half of my waking hours.I have severe nerve pain or numbness.I am currently taking bisphosphonates and low dose corticosteroids.My kidney function is reduced with a creatinine clearance below 30 mL/min.You have a disease that can be measured using specific guidelines.I have received up to 160 mg of steroids for treatment.I am a male willing to use effective contraception and not donate sperm.I have a history of lung or breathing problems.I have known heart problems.I have been diagnosed with a specific blood disorder.I am a woman who is either postmenopausal, surgically sterile, or not pregnant.I agree not to donate blood during and for 8 weeks after my treatment.I have been diagnosed with multiple myeloma according to IMWG 2014 criteria.I am allergic or react badly to the study drugs or similar medications.I have not undergone plasmapheresis in the last 28 days.My liver is not working properly.I am not pregnant or breastfeeding.I've had up to 2 doses of bortezomib to stabilize my condition.I have not been diagnosed or treated for another cancer within the last 2 years.Your platelet count is less than 75,000 cells/mm^3 when you get tested before joining the study.I had major surgery less than 4 weeks ago or am still dealing with its side effects.You have had a bad reaction to steroid medication in the past.I have not had radiotherapy within the restricted time before joining.I do not have any serious illnesses like uncontrolled diabetes or infections.Your body has less than 1000 white blood cells per cubic millimeter at the time of screening.I have been treated with anti-CD38 therapy before.You have certain infectious diseases in your blood.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (daratumumab-based treatment)
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.
In what ways is Daratumumab usually employed as a medical treatment?
"Daratumumab is frequently utilized in the treatment of ophthalmia, sympathetic. It can also be beneficial for those suffering from branch retinal vein occlusion, macular edema and having experienced at least two separate systemic chemotherapies."
Answered by AI
How many participants are taking part in the clinical trial?
"Indeed, the clinicaltrials.gov website states that this trial is actively seeking patients with an initial posting date of May 7th 2020 and a more recent update June 13th 2022. The study requires 25 individuals to be recruited from 1 medical centre."
Answered by AI
Is it possible to register for this clinical experiment at this time?
"Correct. The clinical trial registry on clinicialtrials.gov indicates that this medical study, initially posted on May 7th 2020, is actively recruiting patients. 25 participants need to be enrolled from one centre."
Answered by AI
Has Daratumumab been endorsed by the FDA?
"After careful consideration, our team at Power assigned Daratumumab a score of 2 as this is still in phase two and there has not been any evidence to demonstrate its efficacy. However, prior clinical data does support the medication's safety."
Answered by AI
What prior research has been conducted regarding Daratumumab's efficacy?
"Presently, there are 788 clinical trials running for Daratumumab; 172 of these active studies have reached Phase 3 status. Although the majority of these reside in Mishawaka, Indiana, a myriad of other sites across the US also offer this particular treatment."
Answered by AI
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