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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
Study 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 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.
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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
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 moreOther 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 moreSide effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613460%
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%
Arthralgia
20%
Oedema peripheral
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%
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%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Nasal congestion
6%
Abdominal pain
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Pneumonia cytomegaloviral
1%
Pleural effusion
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Febrile neutropenia
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Bronchitis chronic
1%
Squamous cell carcinoma of skin
1%
Humerus fracture
1%
Respiratory failure
1%
Gastroenteritis
1%
Pathological fracture
1%
Femur fracture
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
~2590
Lenalidomide
2005
Completed Phase 3
~1480
Daratumumab
2014
Completed Phase 3
~1860
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
13,665 Previous Clinical Trials
40,925,566 Total Patients Enrolled
65 Trials studying Plasma Cell Myeloma
8,048 Patients Enrolled for Plasma Cell 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many test subjects are actively participating in this experiment?
"Indeed, the clinicaltrials.gov website contains information indicating that this study is recruiting patients. This particular trial was first posted on April 30th, 2019 and was last edited on December 1st, 2021. A total of 288 participants are needed for the study, which is taking place at 100 different sites."
Answered by AI
Are there any precedents for Daratumumab's usage in medical research?
"Manitoba Blood & Marrow Transplant Program CancerCare Manitoba was the first to study daratumumab in 2002. As of now, there are 1596 completed studies and 776 live trials being conducted, many of which taking place in Lakewood, Colorado."
Answered by AI
What is the lofty goal of this clinical trial?
"The goal of this clinical trial is to measure overall survival (OS) over a 24-cycle treatment period (each cycle lasting 28 days). Secondary outcomes include the incidence of grade 3 or higher infusion-related reactions during cycle 1, as well as the rates of worst grade 3 or higher non-hematologic treatment-related events. Response rates of very good partial response (VGPR) or better and partial response (PR) or better will also be compared. ineligible patients are excluded from the analysis and unevaluable patients are counted in the denominator. Lastly, progression-free survival (PFS) will be estimated using the"
Answered by AI
Has Daratumumab been cleared by the FDA?
"Daratumumab is considered safe according to our team's estimation, as it has received a score of 3. This is because phase 3 trials have shown some efficacy and multiple rounds of data supporting safety."
Answered by AI
What are some of the key ways that Daratumumab has been shown to be effective?
"Most often, Daratumumab is used to treat ophthalmia and sympathetic. However, it has also been shown to be effective in treating branch retinal vein occlusion, macular edema, and at least two prior systemic chemotherapy regimens."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
PCR Oncology
Why did patients apply to this trial?
La necesidad de ganar dinero extra.
PatientReceived no prior treatments
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