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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

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 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%
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%
Hyperglycaemia
7%
Pain in extremity
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%
General physical health deterioration
1%
Syncope
1%
Pulmonary embolism
1%
Pulmonary Embolism
1%
Weight Decreased
1%
Lower respiratory tract infection
1%
Myocardial Infarction
1%
Lower Respiratory Tract Infection
1%
Abdominal Pain
1%
Orthostatic Hypotension
1%
General Physical Health Deterioration
1%
Dehydration
1%
Hyponatraemia
1%
Condition aggravated
1%
Orthostatic hypotension
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: 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

Find a Location

Who is running the clinical trial?

Janssen PharmaceuticalsIndustry Sponsor
82 Previous Clinical Trials
205,141 Total Patients Enrolled
12 Trials studying Multiple Myeloma
710 Patients Enrolled for Multiple Myeloma
Multiple Myeloma Research ConsortiumNETWORK
20 Previous Clinical Trials
1,286 Total Patients Enrolled
19 Trials studying Multiple Myeloma
1,233 Patients Enrolled for Multiple Myeloma
Blood Cancer Research PartnershipOTHER
4 Previous Clinical Trials
189 Total Patients Enrolled
2 Trials studying Multiple Myeloma
59 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03236428 — Phase 2
Multiple Myeloma Research Study Groups: Daratumumab
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT03236428 — Phase 2
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03236428 — Phase 2
~10 spots leftby Oct 2026
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