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Proteasome Inhibitor

Daratumumab-Based Regimens for Multiple Myeloma (DeRIVE Trial)

Phase 2

Waitlist Available

Led By Ajay Nooka, MD, MPH

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Male patients, even if surgically sterilized, must agree to specified contraception methods

Must not have

Systemic treatment within specified days before the first dose of ixazomib with strong cytochrome P450, family 3, subfamily A (CYP3A) inducers or use of St. John's wort

Poor tolerability or known allergy to any of the study drugs or compounds of similar chemical or biologic composition to dexamethasone, boron or mannitol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years after study start

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing daratumumab, ixazomib, dexamethasone, and bortezomib as a possible treatment for newly diagnosed multiple myeloma.

Who is the study for?

This trial is for adults with newly diagnosed multiple myeloma who are in good physical condition (ECOG PS 0-1) and have measurable disease. They can't have had certain other conditions or treatments, must agree to contraception if applicable, and be willing to follow the study rules. Pregnant women, those with allergies to study drugs, or patients treated previously with similar drugs are excluded.

What is being tested?

The trial is testing a combination of daratumumab, ixazomib, and dexamethasone against the same combo plus bortezomib in treating new multiple myeloma cases. It aims to see which regimen is more effective at stopping cancer growth by comparing these two treatment groups.

What are the potential side effects?

Possible side effects include immune system reactions like infusion-related symptoms, blood cell count changes leading to increased infection risk or bleeding problems, potential nerve damage causing numbness or pain, digestive issues such as nausea or constipation, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I agree to use contraception as required.

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I have multiple myeloma with specific signs as per IMWG 2014.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken strong CYP3A inducers or St. John's wort recently.

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I am allergic or react badly to dexamethasone, boron, mannitol, or similar drugs.

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I have been treated with anti-CD38 therapy before.

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I have taken more than 160 mg of steroids or more than 2 doses of bortezomib.

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I have not had radiotherapy in the days leading up to joining.

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I have been diagnosed with a specific blood or bone marrow condition.

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My cancer has spread to my brain or spinal cord.

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I do not have serious heart, stroke, COPD, or uncontrolled asthma issues.

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I have been treated with or been part of a study involving ixazomib.

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I have nerve, kidney, blood, liver, or heart issues.

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I had major surgery less than 4 weeks ago or am still dealing with its side effects.

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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years after study start

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years after study start

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years after study start for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

≥ Very good partial response (VGPR) response rate

Secondary study objectives

Best response on study

Duration of response (DOR)

Minimal residual disease (MRD)

+4 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%

Back Pain

10%

Pneumonia

10%

Neutropenia

Dyspnoea

Oedema peripheral

Oedema Peripheral

Pain in extremity

Hyperglycaemia

Pain in Extremity

Arthralgia

Headache

Paraesthesia

Bronchitis

Bone pain

Epistaxis

Bone Pain

Decreased Appetite

Dyspepsia

Hypocalcaemia

Leukopenia

Hypokalaemia

Decreased appetite

Lymphopenia

Oedema

Vomiting

Hypotension

Alanine aminotransferase increased

Abdominal pain

Nasopharyngitis

Alanine Aminotransferase Increased

Hypertension

Hypophosphataemia

Rash

Abdominal Pain Upper

Conjunctivitis

Abdominal pain upper

Influenza

Muscle Spasms

Musculoskeletal Chest Pain

Muscle spasms

Aspartate aminotransferase increased

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

General physical health deterioration

Hyponatraemia

Condition aggravated

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (DVd, DId)Experimental Treatment4 Interventions

INDUCTION CYCLES 1-3: Patients receive dexamethasone IV and PO on days 1, 8, and 15, daratumumab IV on days 1, 8, and 15, and bortezomib subcutaneously (SC) on days 1, 4, 8, and 11. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. INDUCTION CYCLES 4-8: Patients receive dexamethasone IV and PO on days 1, 8, 15, and 22, daratumumab IV on days 1 and 15, and ixazomib PO on days 1, 8, and 15. Treatment repeats every 28 days for 5 cycles in the absence of disease progression or unacceptable toxicity. Eligible patients then undergo stem cell transplant per standard of care. Patients who have at least stable disease after induction and patients who have undergone transplant continue to Maintenance. MAINTENANCE: Patients receive dexamethasone IV on day 1, daratumumab IV on day 1, and ixazomib PO on days 1, 8, and 15. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (DId)Experimental Treatment3 Interventions

INDUCTION: Patients receive dexamethasone IV and PO on days 1, 8, 15, and 22, daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2 and on days 1 and 15 of cycles 3-8, and ixazomib PO on days 1, 8, and 15. Treatment repeats every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Eligible patients then undergo stem cell transplant per standard of care. Patients who have at least stable disease after induction and patients who have undergone transplant continue to Maintenance. MAINTENANCE: Patients receive dexamethasone IV and PO on days 1, 8, 15, and 22, daratumumab IV on day 1, and ixazomib PO on days 1, 8, and 15. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixazomib

2017

Completed Phase 4

~3510

Bortezomib

2005

Completed Phase 3

~1410