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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
Pivotal Trial
No Placebo-Only Group

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Functional Assessment of Cancer Therapy-General (FACT-G) score
Overall survival (OS)
Secondary study objectives
Best response on treatment based on International Myeloma Working Group (IMWG) criteria
Change in FACT-G score
Early SC mobilization feasibility
+7 more
Other study objectives
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
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%
Back Pain
10%
Pneumonia
10%
Neutropenia
9%
Dyspnoea
8%
Oedema peripheral
8%
Oedema Peripheral
7%
Pain in extremity
7%
Hyperglycaemia
6%
Pain in Extremity
6%
Arthralgia
6%
Headache
6%
Paraesthesia
6%
Bronchitis
5%
Bone pain
5%
Epistaxis
5%
Bone Pain
5%
Decreased Appetite
5%
Dyspepsia
5%
Hypocalcaemia
5%
Leukopenia
5%
Hypokalaemia
5%
Decreased appetite
4%
Lymphopenia
4%
Oedema
4%
Vomiting
4%
Hypotension
4%
Alanine aminotransferase increased
4%
Abdominal pain
4%
Nasopharyngitis
4%
Alanine Aminotransferase Increased
3%
Hypertension
3%
Hypophosphataemia
3%
Rash
3%
Abdominal Pain Upper
3%
Conjunctivitis
3%
Abdominal pain upper
3%
Influenza
2%
Muscle Spasms
2%
Musculoskeletal Chest Pain
2%
Muscle spasms
2%
Aspartate aminotransferase increased
2%
Urinary tract infection
2%
Myalgia
2%
Herpes zoster
2%
Musculoskeletal chest pain
2%
Herpes Zoster
1%
Respiratory failure
1%
Pulmonary Embolism
1%
Weight Decreased
1%
Pulmonary embolism
1%
Myocardial infarction
1%
Dehydration
1%
Myocardial Infarction
1%
Lower Respiratory Tract Infection
1%
Abdominal Pain
1%
Orthostatic Hypotension
1%
General Physical Health Deterioration
1%
General physical health deterioration
1%
Hyponatraemia
1%
Condition aggravated
1%
Orthostatic hypotension
1%
Lower respiratory tract infection
1%
Syncope
1%
Productive cough
1%
Nasal congestion
1%
Weight decreased
1%
Chills
1%
Gastroenteritis
1%
Sepsis
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2650
Lenalidomide
2005
Completed Phase 3
~2240
Daratumumab
2014
Completed Phase 3
~2000

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
120 Previous Clinical Trials
179,589 Total Patients Enrolled
2 Trials studying Plasma Cell Myeloma
2,537 Patients Enrolled for Plasma Cell Myeloma
National Cancer Institute (NCI)NIH
13,893 Previous Clinical Trials
41,012,184 Total Patients Enrolled
64 Trials studying Plasma Cell Myeloma
8,530 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
~145 spots leftby Dec 2029
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