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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 below
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I can take care of myself and perform daily activities.
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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.
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I have high-risk smoldering multiple myeloma based on specific health indicators.

PRISM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134
60%
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%
Oedema peripheral
20%
Arthralgia
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%
Musculoskeletal chest pain
10%
Muscle spasms
9%
Leukopenia
9%
Urinary tract infection
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
8%
Weight decreased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Abdominal pain
6%
Aspartate aminotransferase increased
6%
Myalgia
6%
Nasal congestion
5%
Chills
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Throat irritation
5%
Productive cough
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Acute kidney injury
2%
Atrial fibrillation
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Hip fracture
1%
Femur fracture
1%
Pulmonary sepsis
1%
Pathological fracture
1%
Squamous cell carcinoma of skin
1%
Lower Respiratory Tract Infection
1%
Rib fracture
1%
Pneumonia cytomegaloviral
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Humerus fracture
1%
Pleural effusion
1%
Respiratory failure
1%
Gastroenteritis
1%
Bronchitis chronic
1%
Febrile neutropenia
1%
Angina unstable
1%
Lower respiratory tract infection
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
161 Previous Clinical Trials
307,994 Total Patients Enrolled
23 Trials studying Multiple Myeloma
9,122 Patients Enrolled for Multiple Myeloma
Omar NadeemLead Sponsor

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04775550 — Phase 2
Multiple Myeloma Research Study Groups: Daratumumab, Bortezomib,Lenalidomide,Dexamethasone
Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT04775550 — Phase 2
Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04775550 — Phase 2
~21 spots leftby Mar 2026
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