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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

Approved for 60 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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%

Nausea

11%

Neuralgia

11%

Pyrexia

11%

Dizziness

10%

Back Pain

10%

Pneumonia

10%

Back pain

10%

Neutropenia

Dyspnoea

Oedema peripheral

Oedema Peripheral

Pain in extremity

Hyperglycaemia

Pain in Extremity

Headache

Arthralgia

Paraesthesia

Bronchitis

Bone pain

Epistaxis

Bone Pain

Decreased Appetite

Hypocalcaemia

Dyspepsia

Leukopenia

Hypokalaemia

Decreased appetite

Lymphopenia

Oedema

Vomiting

Hypotension

Alanine aminotransferase increased

Abdominal pain

Nasopharyngitis

Alanine Aminotransferase Increased

Hypertension

Rash

Abdominal Pain Upper

Conjunctivitis

Hypophosphataemia

Abdominal pain upper

Influenza

Muscle Spasms

Musculoskeletal Chest Pain

Aspartate aminotransferase increased

Muscle spasms

Urinary tract infection

Myalgia

Herpes zoster

Musculoskeletal chest pain

Herpes Zoster

Pulmonary Embolism

Weight Decreased

Pulmonary embolism

Myocardial infarction

Dehydration

Myocardial Infarction

Lower Respiratory Tract Infection

Abdominal Pain

Orthostatic Hypotension

General Physical Health Deterioration

Condition aggravated

General physical health deterioration

Hyponatraemia

Orthostatic hypotension

Lower respiratory tract infection

Syncope

Productive cough

Nasal congestion

Respiratory failure

Weight decreased

Chills

Gastroenteritis

Sepsis

Respiratory Failure

Condition Aggravated

100%

80%

60%

40%

20%

Study treatment Arm

Bortezomib + Dexamethasone (Vd)

Daratumumab + Bortezomib and Dexamethasone (DVd)

Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

Awards & Highlights

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.

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