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Monoclonal Antibodies

Treatment (daratumumab) for Myelodysplastic Syndrome

Phase 2
Waitlist Available
Led By Gautam Borthakur
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3.5 years
Awards & highlights

Study Summary

This trial is testing how well daratumumab works in treating patients with leukemia or myelodysplastic syndrome that has come back or does not respond to treatment.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • Acute Myelogenous Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participants With a Response
Secondary outcome measures
Overall Survival
Progression Free Survival
Time on Treatment
Other outcome measures
Biomarkers predictive of response or resistance to therapy

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134
60%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Oedema peripheral
20%
Arthralgia
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Lymphopenia
14%
Pain in extremity
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Musculoskeletal chest pain
10%
Muscle spasms
9%
Urinary tract infection
9%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Hypocalcaemia
7%
Herpes zoster
7%
Influenza
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Abdominal pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Nasal congestion
5%
Chills
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Throat irritation
5%
Productive cough
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Acute kidney injury
2%
Atrial fibrillation
2%
Sepsis
2%
Atrial Fibrillation
1%
Femur fracture
1%
Squamous cell carcinoma of skin
1%
Pneumonia cytomegaloviral
1%
Pulmonary sepsis
1%
Lower Respiratory Tract Infection
1%
Rib fracture
1%
Acute myocardial infarction
1%
Humerus fracture
1%
Hip fracture
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Cerebrovascular accident
1%
Pathological fracture
1%
Ischaemic stroke
1%
Pleural effusion
1%
Respiratory failure
1%
Gastroenteritis
1%
Bronchitis chronic
1%
Febrile neutropenia
1%
Angina unstable
1%
Lower respiratory tract infection
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (daratumumab)Experimental Treatment1 Intervention
Patients receive daratumumab IV over 3.25-6.5 hours on days 1, 8, 15 and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and on day 1 of subsequent cycles. Cycles repeat every 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1960

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,999 Previous Clinical Trials
1,794,084 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,734 Previous Clinical Trials
40,967,597 Total Patients Enrolled
Gautam BorthakurPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
426 Total Patients Enrolled
~1 spots leftby Jun 2025
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