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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
Must not have
Uncontrolled intercurrent illness
Subject has known chronic obstructive pulmonary disease (COPD) or severe, persistent asthma with a Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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.
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.
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.

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.
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I am 18 years old or older.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any unmanaged ongoing illnesses.
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I have COPD or severe asthma with low lung function.
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I am not currently receiving any other cancer treatments.
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I have symptoms of multiple myeloma or signs that indicate it's active.
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I have received treatment for active Myeloma before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of high risk smoldering multiple myeloma (SMM) patients who are MRD negative (MRD-)
Secondary study objectives
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
44%
Thrombocytopenia
38%
Peripheral sensory neuropathy
38%
Peripheral Sensory Neuropathy
32%
Anaemia
24%
Fatigue
22%
Diarrhoea
17%
Upper respiratory tract infection
17%
Upper Respiratory Tract Infection
16%
Constipation
15%
Insomnia
15%
Asthenia
13%
Cough
11%
Neuralgia
11%
Pyrexia
11%
Dizziness
11%
Nausea
10%
Back pain
10%
Back Pain
10%
Pneumonia
10%
Neutropenia
9%
Dyspnoea
8%
Oedema peripheral
8%
Oedema Peripheral
7%
Pain in extremity
7%
Hyperglycaemia
6%
Pain in Extremity
6%
Bronchitis
6%
Headache
6%
Paraesthesia
6%
Arthralgia
5%
Dyspepsia
5%
Bone pain
5%
Bone Pain
5%
Hypocalcaemia
5%
Decreased Appetite
5%
Epistaxis
5%
Leukopenia
5%
Decreased appetite
5%
Hypokalaemia
4%
Lymphopenia
4%
Abdominal pain
4%
Alanine aminotransferase increased
4%
Vomiting
4%
Oedema
4%
Nasopharyngitis
4%
Hypotension
4%
Alanine Aminotransferase Increased
3%
Abdominal Pain Upper
3%
Conjunctivitis
3%
Abdominal pain upper
3%
Influenza
3%
Hypophosphataemia
3%
Rash
3%
Hypertension
2%
Myalgia
2%
Muscle Spasms
2%
Muscle spasms
2%
Musculoskeletal Chest Pain
2%
Urinary tract infection
2%
Aspartate aminotransferase increased
2%
Herpes zoster
2%
Musculoskeletal chest pain
2%
Herpes Zoster
1%
Nasal congestion
1%
Pulmonary Embolism
1%
Weight Decreased
1%
Lower respiratory tract infection
1%
Myocardial Infarction
1%
Pulmonary embolism
1%
Lower Respiratory Tract Infection
1%
Abdominal Pain
1%
Orthostatic Hypotension
1%
General Physical Health Deterioration
1%
Dehydration
1%
Hyponatraemia
1%
Condition aggravated
1%
Syncope
1%
Orthostatic hypotension
1%
General physical health deterioration
1%
Weight decreased
1%
Chills
1%
Myocardial infarction
1%
Gastroenteritis
1%
Sepsis
1%
Respiratory failure
1%
Productive cough
1%
Respiratory Failure
1%
Condition Aggravated
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bortezomib + Dexamethasone (Vd)
Daratumumab + Bortezomib and Dexamethasone (DVd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

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
2 Previous Clinical Trials
110 Total Patients Enrolled
2 Trials studying Multiple Myeloma
110 Patients Enrolled for Multiple Myeloma
Janssen, LPIndustry Sponsor
166 Previous Clinical Trials
308,747 Total Patients Enrolled
25 Trials studying Multiple Myeloma
9,602 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
~17 spots leftby Mar 2026
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