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Monoclonal Antibodies

Daratumumab for Smoldering Multiple Myeloma

Phase 2

Waitlist Available

Led By Irene Ghobrial, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Must meet criteria for high-risk MGUS or low-risk smoldering myeloma as described

Must not have

Subject has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted normal

Major surgery within 4 weeks before enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well daratumumab works in treating patients with Monoclonal Gammopathy of Unknown Significance (MGUS) or Smoldering Multiple Myeloma (SMM).

Who is the study for?

Adults with high-risk MGUS or low-risk Smoldering Multiple Myeloma who haven't had treatment for these conditions can join. They must be in decent health, have certain blood and organ function levels, not be pregnant, and able to consent. Excluded are those with recent cancers (with exceptions), severe illnesses, major surgery within the last month, or on other clinical trials.

What is being tested?

The trial is testing Daratumumab as a potential treatment for Monoclonal Gammopathy of Unknown Significance (MGUS) and Smoldering Multiple Myeloma (SMM). It's a Phase II study which means they're looking at how effective this drug is and gathering more information about its safety.

What are the potential side effects?

Daratumumab may cause immune system reactions like infusion-related responses. There could also be effects on blood cells leading to higher infection risk, fatigue, nausea, or liver issues. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My condition is either high-risk MGUS or low-risk smoldering myeloma.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I have COPD with less than half the normal lung function.

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I have not had major surgery in the last 4 weeks.

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I have had moderate to severe asthma in the last 2 years or currently have uncontrolled asthma.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have a serious heart condition.

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I am not currently receiving any experimental treatments.

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I have received treatment for Multiple Myeloma.

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I am not currently using any treatments known to work against myeloma.

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

The Proportion Of Patients In Deep Response

Secondary study objectives

Complete Response Rate

Duration of Response

Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)

+3 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: DaratumumabExperimental Treatment1 Intervention

Daratumumab will be administered by IV infusion weekly during cycles 1 and 2 Daratumumab will be administered by IV infusion every other week during cycles 3 through 6 Daratumumab will be administered by IV infusion monthly during cycles 7 through 20

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab

2014

Completed Phase 3

~2000

0 / 11Eligibility criteria met