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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 belowSelect...
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.
Select...
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.
Select...
I do not have severe health issues that are uncontrolled, including seizures, infections, or severe heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
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 moreOther 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 moreSide effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613444%
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%
Asthenia
15%
Insomnia
13%
Cough
11%
Nausea
11%
Pyrexia
11%
Dizziness
11%
Neuralgia
10%
Back Pain
10%
Pneumonia
10%
Back pain
10%
Neutropenia
9%
Dyspnoea
8%
Oedema peripheral
8%
Oedema Peripheral
7%
Hyperglycaemia
7%
Pain in extremity
6%
Pain in Extremity
6%
Paraesthesia
6%
Headache
6%
Bronchitis
6%
Arthralgia
5%
Epistaxis
5%
Bone pain
5%
Bone Pain
5%
Decreased Appetite
5%
Dyspepsia
5%
Leukopenia
5%
Hypokalaemia
5%
Decreased appetite
5%
Hypocalcaemia
4%
Lymphopenia
4%
Oedema
4%
Vomiting
4%
Hypotension
4%
Abdominal pain
4%
Alanine aminotransferase increased
4%
Nasopharyngitis
4%
Alanine Aminotransferase Increased
3%
Abdominal pain upper
3%
Hypertension
3%
Abdominal Pain Upper
3%
Hypophosphataemia
3%
Conjunctivitis
3%
Rash
3%
Influenza
2%
Muscle Spasms
2%
Musculoskeletal Chest Pain
2%
Muscle spasms
2%
Aspartate aminotransferase increased
2%
Myalgia
2%
Herpes zoster
2%
Musculoskeletal chest pain
2%
Urinary tract infection
2%
Herpes Zoster
1%
Weight decreased
1%
Pulmonary Embolism
1%
Nasal congestion
1%
Weight Decreased
1%
Pulmonary embolism
1%
Myocardial infarction
1%
Dehydration
1%
Myocardial Infarction
1%
Sepsis
1%
Lower Respiratory Tract Infection
1%
Abdominal Pain
1%
Orthostatic Hypotension
1%
General Physical Health Deterioration
1%
Condition aggravated
1%
General physical health deterioration
1%
Hyponatraemia
1%
Productive cough
1%
Orthostatic hypotension
1%
Syncope
1%
Lower respiratory tract infection
1%
Respiratory failure
1%
Chills
1%
Gastroenteritis
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
~2380
Find a Location
Who is running the clinical trial?
ECOG-ACRIN Cancer Research GroupLead Sponsor
121 Previous Clinical Trials
179,909 Total Patients Enrolled
3 Trials studying Multiple Myeloma
3,137 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,829 Total Patients Enrolled
594 Trials studying Multiple Myeloma
191,129 Patients Enrolled for Multiple Myeloma
Natalie S CallanderPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, will test regularly, and use birth control during treatment.I must have a specific urine test monthly if my initial results show a high protein level.I was diagnosed with a high-risk form of smoldering multiple myeloma less than a year ago and I don't have symptoms.I will use a condom and not donate sperm during and after the study.My tests show I have at least two markers indicating a blood disorder.Your blood tests show: Hemoglobin is at least 11 g/dL, platelet count is at least 100,000 cells/mm^3, and absolute neutrophil count is at least 1500 cells/mm^3. Your kidney function (creatinine clearance) is at least 30 mL/min, and your liver function (bilirubin, SGPT, and SGOT) is within normal range.I don't have bone damage, tumors outside the bone marrow, or high calcium levels without explanation.I haven't had treatments for myeloma and don't take certain medications.I do not have severe COPD or asthma that has been problematic in the last 2 years.I have no allergies to daratumumab, lenalidomide, or dexamethasone.I do not have severe health issues that are uncontrolled, including seizures, infections, or severe heart failure.I am HIV positive with an undetectable viral load in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (lenalidomide, dexamethasone)
- Group 2: Arm I (daratumumab, lenalidomide, dexamethasone)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.