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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

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

Urinary tract infection

Muscular weakness

Musculoskeletal chest pain

Tremor

Hyperglycaemia

Headache

Hypertension

Leukopenia

Respiratory Tract Infection

Influenza like illness

Vomiting

Muscular Weakness

Vision blurred

Abdominal pain

Influenza

Blood creatinine increased

Hypocalcaemia

Hypomagnesaemia

Bone pain

Myalgia

Neuropathy peripheral

Oropharyngeal pain

Peripheral Sensory Neuropathy

Lymphopenia

Musculoskeletal Chest Pain

Musculoskeletal Pain

Dysgeusia

Neuropathy Peripheral

Abdominal pain upper

Sinusitis

Alanine aminotransferase increased

Weight decreased

Hypophosphataemia

Neck pain

Renal impairment

Epistaxis

Vision Blurred

Anxiety

Renal Impairment

Bone Pain

Abdominal Pain

Abdominal Pain Upper

Acute kidney injury

Pulmonary embolism

Toothache

Lower respiratory tract infection

Contusion

Fall

Paraesthesia

Dyspnoea exertional

Productive cough

Hyperhidrosis

Influenza Like Illness

Alanine Aminotransferase Increased

Acute Kidney Injury

Pulmonary Embolism

Sepsis

Atrial fibrillation

Dyspepsia

Gastroenteritis

Hypoaesthesia

Dysphonia

Rhinorrhoea

Hypotension

Chills

Weight Decreased

Depression

Renal failure

Non-cardiac chest pain

Stomatitis

Conjunctivitis

Rhinitis

Nasal congestion

Haematoma

Infection

Atrial Fibrillation

Osteonecrosis of Jaw

Renal Failure

Febrile Neutropenia

Clostridium Difficile Infection

Spinal Column Stenosis

Acute Myocardial Infarction

Lower Respiratory Tract Infection

Osteomyelitis

Femur fracture

Gout

Osteoarthritis

Osteonecrosis of jaw

Pathological fracture

Spinal stenosis

Plasma cell leukaemia

Febrile neutropenia

Acute myocardial infarction

Facial paralysis

Colitis

Pain

Cellulitis

Clostridium difficile infection

Ischaemic stroke

Loss of consciousness

Lung disorder

Pleural effusion

Tachycardia

Rhinitis allergic

Plasma Cell Leukaemia

100%

80%

60%

40%

20%

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