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Immunotherapy

Lenalidomide + Dexamethasone +/- Daratumumab for Multiple Myeloma

Phase 3
Recruiting
Led By Natalie S Callander
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women must not be pregnant and must have a negative pregnancy test before and during treatment, and use effective contraception
NOTE: UPEP (on a 24-hour collection) is required; no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hour (hr), and urine in addition to serum must be followed in order to confirm a very good partial response (VGPR) or higher response.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Summary

This trial is testing Lenalidomide + Dexamethasone with or without Daratumumab to see if it can better treat patients with high-risk smoldering myeloma.

Who is the study for?
This trial is for adults with high-risk smoldering myeloma diagnosed within the last year. Participants must not have severe heart failure, active infections, or certain other health conditions. They should not be pregnant and must use effective contraception. Prior cancer treatments are disallowed except if it was curative and the patient has been disease-free for a set period.Check my eligibility
What is being tested?
The study tests lenalidomide and dexamethasone with or without daratumumab in patients with high-risk smoldering myeloma. It aims to see if adding daratumumab improves outcomes by altering the immune system's response to tumor cells.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system, such as infusion reactions from daratumumab, blood clots due to lenalidomide, and increased risk of infections. Dexamethasone can cause mood swings, weight gain, and elevated blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant, will test regularly, and use birth control during treatment.
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I must have a specific urine test monthly if my initial results show a high protein level.
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I don't have bone damage, tumors outside the bone marrow, or high calcium levels without explanation.
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I haven't had treatments for myeloma and don't take certain medications.
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I do not have severe COPD or asthma that has been problematic in the last 2 years.
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I do not have severe health issues that are uncontrolled, including seizures, infections, or severe heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 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
Functional Assessment of Cancer Therapy-General (FACT-G) score
Overall survival (OS)
Secondary outcome measures
Best response on treatment based on International Myeloma Working Group (IMWG) criteria
Change in FACT-G score
Early SC mobilization feasibility
+7 more
Other outcome measures
Adherence Starts with Knowledge (ASK)-12 scores
Cumulative dose calculated as the sum of all doses taken across all cycles
Dose intensity calculated as cumulative dose received divided by treatment duration
+7 more

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%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Bone pain
9%
Leukopenia
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%
Throat irritation
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Pathological fracture
1%
Femur fracture
1%
Pleural effusion
1%
Lower Respiratory Tract Infection
1%
Angina unstable
1%
Pulmonary sepsis
1%
Hypercalcaemia
1%
Acute myocardial infarction
1%
Hip fracture
1%
Pulmonary Sepsis
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Ischaemic stroke
1%
Rib fracture
1%
Respiratory failure
1%
Gastroenteritis
1%
Bronchitis chronic
1%
Cerebrovascular accident
1%
Febrile neutropenia
1%
Lower respiratory tract infection
1%
Humerus fracture
1%
Squamous cell carcinoma of skin
1%
Pneumonia cytomegaloviral
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

2Treatment groups
Experimental Treatment
Group I: Arm II (lenalidomide, dexamethasone)Experimental Treatment4 Interventions
Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 of courses 1-12. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (daratumumab, lenalidomide, dexamethasone)Experimental Treatment4 Interventions
Patients receive daratumumab IV on days 1, 8, 15, and 22 of courses 1-2, days 1 and 15 of courses 3-6, and day 1 of courses 7-24. Patients also receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 in courses 1-12. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2640
Lenalidomide
2005
Completed Phase 3
~1340
Daratumumab
2014
Completed Phase 3
~2000

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,634 Total Patients Enrolled
2 Trials studying Plasma Cell Myeloma
2,537 Patients Enrolled for Plasma Cell Myeloma
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,113 Total Patients Enrolled
64 Trials studying Plasma Cell Myeloma
7,944 Patients Enrolled for Plasma Cell Myeloma
Natalie S CallanderPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Daratumumab (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03937635 — Phase 3
Plasma Cell Myeloma Research Study Groups: Arm II (lenalidomide, dexamethasone), Arm I (daratumumab, lenalidomide, dexamethasone)
Plasma Cell Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT03937635 — Phase 3
Daratumumab (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03937635 — Phase 3
~152 spots leftby Dec 2029