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Proteasome Inhibitor
Quadruple Drug Therapy for Multiple Myeloma
Phase 2
Recruiting
Led By Ajai Chari, MD
Research Sponsored by Larysa Sanchez
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed, untreated, symptomatic MM as defined by standard criteria with clonal bone marrow plasma cells >10% or biopsy-proven bony or extramedullary plasmacytoma
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within a year
Awards & highlights
Study Summary
This trial is testing a new cancer treatment in elderly patients with multiple myeloma who are not eligible for a transplant. The treatment consists of four drugs given in different combinations and doses. Patients will be monitored closely for side effects and how well the treatment works.
Who is the study for?
This trial is for people aged 70 or older with newly diagnosed multiple myeloma who can't have a stem cell transplant. They should be able to perform daily activities (ECOG ≤ 2) and have measurable disease indicators. Men must use contraception if sexually active with women of childbearing potential. People are excluded if they have certain heart, lung, kidney diseases, infections, severe allergies to the drugs being tested, or other health conditions that could affect drug absorption or pose risks.Check my eligibility
What is being tested?
The study tests a combination of subcutaneous daratumumab with lower doses of bortezomib, lenalidomide (revlimid), and dexamethasone in elderly patients who cannot undergo transplantation. The treatment continues until disease progression or unacceptable side effects occur while monitoring for safety and effectiveness.See study design
What are the potential side effects?
Possible side effects include low blood counts leading to increased infection risk; nerve damage causing pain or numbness; digestive issues like nausea; fatigue; allergic reactions to medication components; and potential heart complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been newly diagnosed with multiple myeloma and have not received treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within a year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within a year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Responses: VGPR or better
Secondary outcome measures
Duration of ORR (≥PR), ≥VGPR, ≥CR, and sCR
Number of Adverse Events
Overall Response Rates
+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%
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%
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%
Pleural effusion
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: Daratumumab with dose-attenuated VRdExperimental Treatment5 Interventions
SubQ Daratumumab with Dose-Attenuated VRd
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Daratumumab
2014
Completed Phase 3
~1860
Bortezomib
2005
Completed Phase 2
~1140
Lenalidomide
2005
Completed Phase 3
~1480
Ixazomib
2017
Completed Phase 4
~3370
Find a Location
Who is running the clinical trial?
Larysa SanchezLead Sponsor
Ajai ChariLead Sponsor
4 Previous Clinical Trials
85 Total Patients Enrolled
4 Trials studying Multiple Myeloma
85 Patients Enrolled for Multiple Myeloma
Janssen, LPIndustry Sponsor
160 Previous Clinical Trials
307,972 Total Patients Enrolled
23 Trials studying Multiple Myeloma
9,164 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tested positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.Your platelet count is less than 75,000 cells per cubic millimeter.I haven't had any cancer treatment in the last 3 weeks.Your body has too few infection-fighting white blood cells.I have a GI condition or had a procedure that may affect drug absorption.I am 70 or older, ineligible for a specific stem cell transplant, and can care for myself despite my myeloma.Your hemoglobin level is less than 8 grams per deciliter.I have had severe asthma in the last 2 years or currently have uncontrolled asthma.I have not had major surgery or radiation within the last 2 weeks.I have had a spine surgery within the last week.I am allergic to bortezomib, lenalidomide, dexamethasone, or daratumumab.You have a measurable amount of M-protein in your blood or urine, or abnormal results in a serum free light chain assay.Your liver enzymes (AST or ALT) are three times higher than the normal level.Your blood calcium level has been consistently very high in the past two weeks.I do not have serious heart conditions or recent heart attacks.I haven't needed antibiotics for an infection in the last 14 days.My cancer has spread to my brain or spinal cord.Your bilirubin levels are higher than normal.I am a man and agree to use two forms of birth control.My lung function is less than half of what is expected for someone my age and size.I have no cancer history in the last 3 years, except for certain skin cancers, early-stage cancers, or cervical carcinoma in situ that were treated.I have been newly diagnosed with multiple myeloma and have not received treatment.I have been diagnosed with primary amyloidosis.I am a man who will use protection during sex and won't donate sperm.I have severe nerve damage or moderate damage with pain.My kidney function is very low.I haven't taken NSAIDs, IV contrast, aminoglycosides, or similar drugs in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Daratumumab with dose-attenuated VRd
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.
Has Daratumumab attained regulatory acceptance?
"Daratumumab is deemed to have an intermediate level of safety, scoring a 2. This conclusion was reached because there are some data indicating it's protective properties but none demonstrating its efficacy."
Answered by AI
What medical maladies does Daratumumab typically address?
"Daratumumab is primarily used to treat ophthalmia, sympathetic and has been approved for treating other ailments such as two prior systemic chemotherapy regimens, branch retinal vein occlusion, or macular edema."
Answered by AI
How many participants is this research endeavor accommodating?
"Affirmative. Found on clinicaltrials.gov, this clinical study is actively recruiting patients and was recently updated on November 30th 2021. Since its inception in October 24 2019, the medical research has been seeking 38 participants from a single site."
Answered by AI
Are there available slots for potential participants in this study?
"According to the official clinicaltrials.gov database, this medical study is currently seeking participants; it was first posted on October 24th 2019 and recently modified on November 30th 2021."
Answered by AI
What other research projects have employed Daratumumab to further their findings?
"Currently, there are 172 Daratumumab trials in Phase 3 and 797 studies running in total. Many of these experiments originate from Joliet, Illinois; however all together 27226 locations across the world have at least one trial involving this drug."
Answered by AI
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