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Immunotherapy

Lenalidomide + Dexamethasone +/- Daratumumab for Multiple Myeloma

Adrian, MI
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
No Placebo-Only Group
Pivotal Trial

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 2023 Phase 3 trial • 569 Patients • NCT02076009
48%
Neutropenia
42%
Anaemia
37%
Diarrhoea
32%
Thrombocytopenia
31%
Fatigue
27%
Constipation
26%
Upper respiratory tract infection
23%
Insomnia
22%
Muscle spasms
22%
Nasopharyngitis
20%
Arthralgia
20%
Back pain
19%
Nausea
19%
Muscle Spasms
19%
Upper Respiratory Tract Infection
18%
Oedema peripheral
17%
Asthenia
16%
Back Pain
16%
Bronchitis
15%
Pain in extremity
15%
Cough
14%
Pyrexia
14%
Dyspnoea
13%
Oedema Peripheral
13%
Decreased appetite
13%
Rash
12%
Hypokalaemia
12%
Cataract
11%
Pain in Extremity
11%
Pneumonia
11%
Pruritus
11%
Dizziness
10%
Respiratory tract infection
10%
Peripheral sensory neuropathy
10%
Decreased Appetite
9%
Urinary tract infection
9%
Muscular weakness
9%
Musculoskeletal chest pain
9%
Tremor
8%
Hyperglycaemia
8%
Headache
8%
Hypertension
8%
Leukopenia
8%
Respiratory Tract Infection
7%
Influenza like illness
7%
Vomiting
7%
Muscular Weakness
6%
Vision blurred
6%
Abdominal pain
6%
Influenza
6%
Blood creatinine increased
6%
Hypocalcaemia
6%
Hypomagnesaemia
6%
Bone pain
6%
Myalgia
6%
Neuropathy peripheral
6%
Oropharyngeal pain
6%
Peripheral Sensory Neuropathy
6%
Lymphopenia
6%
Musculoskeletal Chest Pain
5%
Musculoskeletal Pain
5%
Dysgeusia
5%
Neuropathy Peripheral
5%
Abdominal pain upper
5%
Sinusitis
5%
Alanine aminotransferase increased
5%
Weight decreased
5%
Hypophosphataemia
5%
Neck pain
5%
Renal impairment
5%
Epistaxis
5%
Vision Blurred
5%
Anxiety
5%
Renal Impairment
4%
Bone Pain
4%
Abdominal Pain
4%
Abdominal Pain Upper
4%
Acute kidney injury
4%
Pulmonary embolism
4%
Toothache
4%
Lower respiratory tract infection
4%
Contusion
4%
Fall
4%
Paraesthesia
4%
Dyspnoea exertional
4%
Productive cough
4%
Hyperhidrosis
4%
Influenza Like Illness
4%
Alanine Aminotransferase Increased
3%
Acute Kidney Injury
3%
Pulmonary Embolism
3%
Sepsis
3%
Atrial fibrillation
3%
Dyspepsia
3%
Gastroenteritis
3%
Hypoaesthesia
3%
Dysphonia
3%
Rhinorrhoea
3%
Hypotension
3%
Chills
3%
Weight Decreased
3%
Depression
2%
Renal failure
2%
Non-cardiac chest pain
2%
Stomatitis
2%
Conjunctivitis
2%
Rhinitis
2%
Nasal congestion
2%
Haematoma
2%
Infection
1%
Atrial Fibrillation
1%
Osteonecrosis of Jaw
1%
Renal Failure
1%
Febrile Neutropenia
1%
Clostridium Difficile Infection
1%
Spinal Column Stenosis
1%
Acute Myocardial Infarction
1%
Lower Respiratory Tract Infection
1%
Osteomyelitis
1%
Femur fracture
1%
Gout
1%
Osteoarthritis
1%
Osteonecrosis of jaw
1%
Pathological fracture
1%
Spinal stenosis
1%
Plasma cell leukaemia
1%
Febrile neutropenia
1%
Acute myocardial infarction
1%
Facial paralysis
1%
Colitis
1%
Pain
1%
Cellulitis
1%
Clostridium difficile infection
1%
Ischaemic stroke
1%
Loss of consciousness
1%
Lung disorder
1%
Pleural effusion
1%
Tachycardia
1%
Rhinitis allergic
1%
Plasma Cell Leukaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lenalidomide, Low-dose Dexamethasone (Rd)
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)

Awards & Highlights

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

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
Lenalidomide
2005
Completed Phase 3
~2240
Dexamethasone
2007
Completed Phase 4
~2650
Daratumumab
2014
Completed Phase 3
~3290

Find a Location

Closest Location:Hickman Cancer Center· Adrian, MI· 146 miles

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
121 Previous Clinical Trials
159,514 Total Patients Enrolled
3 Trials studying Multiple Myeloma
3,137 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
14,057 Previous Clinical Trials
41,149,145 Total Patients Enrolled
595 Trials studying Multiple Myeloma
191,644 Patients Enrolled for Multiple Myeloma
Natalie S CallanderPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Daratumumab (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03937635 — Phase 3
Multiple Myeloma Research Study Groups: Arm II (lenalidomide, dexamethasone), Arm I (daratumumab, lenalidomide, dexamethasone)
Multiple 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
~133 spots leftby Dec 2029