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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 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 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

Dyspnoea

Oedema peripheral

Oedema Peripheral

Pain in extremity

Hyperglycaemia

Pain in Extremity

Arthralgia

Headache

Paraesthesia

Bronchitis

Bone pain

Epistaxis

Bone Pain

Decreased Appetite

Hypocalcaemia

Dyspepsia

Leukopenia

Hypokalaemia

Decreased appetite

Lymphopenia

Oedema

Vomiting

Hypotension

Alanine aminotransferase increased

Abdominal pain

Nasopharyngitis

Alanine Aminotransferase Increased

Hypertension

Rash

Abdominal Pain Upper

Conjunctivitis

Hypophosphataemia

Abdominal pain upper

Influenza

Muscle Spasms

Musculoskeletal Chest Pain

Aspartate aminotransferase increased

Muscle spasms

Urinary tract infection

Myalgia

Herpes zoster

Musculoskeletal chest pain

Herpes Zoster

Pulmonary Embolism

Weight Decreased

Pulmonary embolism

Myocardial infarction

Dehydration

Myocardial Infarction

Lower Respiratory Tract Infection

Abdominal Pain

Orthostatic Hypotension

General Physical Health Deterioration

Condition aggravated

General physical health deterioration

Hyponatraemia

Orthostatic hypotension

Lower respiratory tract infection

Syncope

Productive cough

Nasal congestion

Respiratory failure

Weight decreased

Chills

Gastroenteritis

Sepsis

Respiratory Failure

Condition Aggravated

100%

80%

60%

40%

20%

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