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Monoclonal Antibodies

Daratumumab-based Therapy for Multiple Myeloma

Phase 2

Waitlist Available

Led By Matthew Pianko, M.D.

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

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

Must have

Baseline bone marrow or tissue sample available for Clonality ID in ClonoSEQ

Participant must be registered in and must comply with all requirements of REMSTM program for lenalidomide

Must not have

Known contraindication to study required medications or appropriate prophylactic medications

Women with a positive pregnancy test during the screening period prior to study initiation or who are lactating

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after week 88, up to 3 years after start of study treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a new combination therapy of drugs will result in more patients achieving minimal residual disease (MRD)-negative status, relative to the standard of care.

Who is the study for?

This trial is for adults with newly diagnosed Multiple Myeloma who have measurable disease and can tolerate treatments, including high-dose chemotherapy and stem cell transplant if needed. Participants must not have had more than one cycle of myeloma therapy before joining, be free from certain blood/liver diseases, HIV, Hepatitis B/C, other active cancers in the last five years, or significant heart or lung conditions.

What is being tested?

The study tests a combination of drugs (daratumumab + lenalidomide + dexamethasone) as initial treatment. If minimal residual disease is detected afterward, an additional drug (bortezomib) is added. The approach adapts to each patient's response to maximize chances of eliminating all signs of cancer at a microscopic level.

What are the potential side effects?

Possible side effects include immune system reactions like infusion-related symptoms with daratumumab; blood clots and skin rash with lenalidomide; weight gain and mood changes with dexamethasone; and nerve damage or digestive issues with bortezomib.

Eligibility Criteria

Inclusion Criteria

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

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I have a bone marrow or tissue sample available for testing.

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I am registered and comply with the REMS program for lenalidomide.

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I am a man willing to follow specific rules about contraception or abstinence.

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I have been diagnosed with active multiple myeloma.

Exclusion Criteria

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

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I am allergic or cannot take certain medications required for this study.

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I am not pregnant or breastfeeding.

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I have tested positive for HIV, Hepatitis B, or Hepatitis C.

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My cancer has spread to my brain or spinal cord.

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I have had a stem cell transplant before.

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I have had another type of cancer in the last 5 years.

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My kidneys are not working well, with a creatinine clearance below 30ml/min.

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My liver function tests are within normal limits.

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I have had only one cycle of treatment for my myeloma.

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I haven't had major surgery in the last 2 weeks or still recovering from one.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after week 88, up to 3 years after start of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after week 88, up to 3 years after start of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and after week 88, up to 3 years after start of study treatment 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 participants who achieve MRD negativity either after induction or, if still MRD-positive after induction, after consolidation.

Secondary study objectives

Health-related quality of life assessment changes from baseline using EuroQol survey "EQ-5D."

Incidence of treatment-emergent adverse events

Neurotoxicity assessment changes from baseline using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire.

+7 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

Arthralgia

Headache

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

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dara-Rd followed by Dara-RVdExperimental Treatment4 Interventions

* Induction regimen with Daratumumab, Lenalidomide and Dexamethasone (Dara-Rd) in all study subjects, weeks 1-24 * Consolidation regimen with Daratumumab, Lenalidomide, Bortezomib and Dexamethasone (Dara-RVd) in post-induction MRD+ population, weeks 25-36 * Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88 * Maintenance regimen with lenalidomide (R) until progression or intolerance

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab

2014

Completed Phase 3

~2000

Lenalidomide

2005

Completed Phase 3

~2240