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Proteasome Inhibitor
DARA-RVD for Smoldering Multiple Myeloma (PRISM Trial)
Phase 2
Recruiting
Research Sponsored by Omar Nadeem, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status (PS) 0, 1, or 2
Detectable clonality sequence by next generation sequencing using clonoSEQ assay to allow for minimal residual disease measurement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
PRISM Trial Summary
This trial is studying whether giving the combination of daratumumab SC, lenalidomide, bortezomib, and dexamethasone works in treating patients with smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma.
Who is the study for?
This trial is for adults over 18 with high-risk smoldering multiple myeloma, who meet specific criteria but do not have active symptoms. Participants must be in good enough health to perform daily activities and agree to birth control measures if applicable. They cannot have had treatment for active myeloma or other cancers within the last two years, among other exclusions.Check my eligibility
What is being tested?
The study tests a combination of drugs: Daratumumab (Darzalex Faspro), Lenalidomide (Revlimid), Bortezomib (Velcade), and Dexamethasone, on preventing smoldering multiple myeloma from becoming symptomatic. It aims to understand the effectiveness of this drug mix.See study design
What are the potential side effects?
Possible side effects include immune system reactions, infections due to lowered white blood cell counts, nerve damage causing pain or numbness, blood clots, fatigue, gastrointestinal issues like constipation or diarrhea, and skin reactions.
PRISM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
Select...
My cancer can be tracked with a specific DNA test for minimal disease.
Select...
I am 18 years old or older.
Select...
I am registered and agree to follow the Revlimid REMS program requirements.
Select...
I have high-risk smoldering multiple myeloma based on specific health indicators.
PRISM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of high risk smoldering multiple myeloma (SMM) patients who are MRD negative (MRD-)
Secondary outcome measures
Duration of Response
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
Objective Response Rate
+1 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%
Femur fracture
1%
Pleural effusion
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
PRISM Trial Design
1Treatment groups
Experimental Treatment
Group I: Daratumumab, Bortezomib,Lenalidomide,DexamethasoneExperimental Treatment4 Interventions
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Cycle Length is 28 days.
The names of the study drugs involved in this study are:
Daratumumab
Bortezomib
Lenalidomide
Dexamethasone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyaluronidase (human recombinant)
FDA approved
Lenalidomide
FDA approved
Bortezomib D-mannitol
FDA approved
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
Omar Nadeem, MDLead Sponsor
1 Previous Clinical Trials
61 Total Patients Enrolled
1 Trials studying Multiple Myeloma
61 Patients Enrolled for Multiple Myeloma
Janssen, LPIndustry Sponsor
160 Previous Clinical Trials
307,930 Total Patients Enrolled
23 Trials studying Multiple Myeloma
9,122 Patients Enrolled for Multiple Myeloma
Omar NadeemLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have HIV, hepatitis B, hepatitis C, or active COVID-19 infection.Your test results need to be within certain numbers.I can take care of myself and perform daily activities.My cancer can be tracked with a specific DNA test for minimal disease.I haven't had or been treated for another cancer in the last 2 years.You do not show signs of specific symptoms related to active multiple myeloma.I am not pregnant, will not become pregnant, and follow the Revlimid safety program.I am 18 years old or older.I am registered and agree to follow the Revlimid REMS program requirements.I do not have any unmanaged ongoing illnesses.You have had allergic reactions to certain substances in the past.I have COPD or severe asthma with low lung function.I have high-risk smoldering multiple myeloma based on specific health indicators.I am not currently receiving any other cancer treatments.I have symptoms of multiple myeloma or signs that indicate it's active.I have received treatment for active Myeloma before.
Research Study Groups:
This trial has the following groups:- Group 1: Daratumumab, Bortezomib,Lenalidomide,Dexamethasone
Awards:
This trial has 3 awards, including:- 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.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Is this research program still recruiting participants?
"Affirmative. Clinicaltrials.gov exhibits that recruitment for this medical experiment is currently underway, originally appearing on April 9th 2021 and last updated October 18th 2021. 30 patients need to be recruited from two separate clinical sites."
Answered by AI
Has Daratumumab attained official sanction from the FDA?
"Our team rates the safety of Daratumumab as a 2, due to preclinical research confirming its security despite there being no evidence yet for efficacy."
Answered by AI
What other research endeavors have been conducted involving Daratumumab?
"Currently, 808 active trials related to Daratumumab are underway with 179 of those experiments in Phase 3. The studies have been established at 28308 locations around the world and a significant number take place in Strasbourg, Other."
Answered by AI
In what circumstances is Daratumumab most frequently prescribed?
"Daratumumab is a medicament utilized to treat ophthalmia and sympathetic. Moreover, it has been shown to be effective in the management of branch retinal vein occlusion, macular edema, as well as two prior systemic chemotherapy regimens."
Answered by AI
How many individuals are being studied as part of this research endeavor?
"Yes, according to clinicaltrials.gov the trial is still seeking participants. It was initiated on April 9th 2021 and recently modified October 18th that same year. The study requires 30 individuals from two separate sites for its completion."
Answered by AI
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