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Monoclonal Antibodies

Daratumumab Combination for Multiple Myeloma

Phase 2

Waitlist Available

Led By Muzaffar H Qazilbash

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have had relapsed disease prior to transplant, or undergone previous autologous stem cell transplant (ASCT), followed by relapse and at least a partial response to salvage therapy

Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2

Must not have

Radiotherapy within 14 days before enrollment

Female subject is pregnant or lactating

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of initiation of maintenance therapy assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing daratumumab, hyaluronidase-fihj, and pomalidomide to see if they work well together to treat patients with relapsed multiple myeloma.

Who is the study for?

This trial is for patients with relapsed multiple myeloma post-stem cell transplant. They must have had a partial response to salvage therapy, be within 60-180 days post-transplant, and have an ECOG status of 0-2. Key eligibility includes adequate kidney function (creatinine <= 2.5 mg/dL), platelet count >= 50,000/mm^3, neutrophil count >= 1000/mm^3, liver enzymes up to three times the normal limit, and no uncontrolled heart arrhythmias.

What is being tested?

The study tests daratumumab with hyaluronidase-fihj and pomalidomide in treating relapsed multiple myeloma after stem cell transplant. Daratumumab is designed to stop cancer cells from growing by targeting specific proteins on their surface while pomalidomide aims to kill or halt the division of cancer cells.

What are the potential side effects?

Potential side effects include infusion reactions related to daratumumab such as coughing or shortness of breath during administration; fatigue; nausea; diarrhea; low blood counts leading to increased infection risk; and possible liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition worsened after initial treatment but improved with further therapy.

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I can take care of myself and am up and about more than half of my waking hours.

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I have recovered from my stem cell transplant side effects.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had radiotherapy in the last 14 days.

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I am currently pregnant or breastfeeding.

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I have had severe or moderate asthma in the last 2 years and it's currently not under control.

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I still have moderate side effects from my last chemotherapy.

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I have not had major surgery in the last 2 weeks.

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I have asthma or COPD with severe lung function restriction.

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My condition did not improve with daratumumab and pomalidomide treatment.

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I had side effects from daratumumab or pomalidomide that I couldn't tolerate.

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My cancer has spread to my brain or spinal cord.

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My condition does not produce measurable proteins, or I have plasma cell leukemia, or I've had a previous transplant from a donor.

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I cannot or will not follow the medication plan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of initiation of maintenance therapy assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of initiation of maintenance therapy assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of initiation of maintenance therapy assessed up to 2 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

Complete remission rate (CRR) defined as achieving a negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow

Progression-free survival (PFS)

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%

Pneumonia

10%

Back pain

10%

Neutropenia

Dyspnoea

Oedema peripheral

Oedema Peripheral

Pain in extremity

Hyperglycaemia

Pain in Extremity

Headache

Arthralgia

Paraesthesia

Bronchitis

Bone pain

Bone Pain

Decreased Appetite

Hypocalcaemia

Dyspepsia

Leukopenia

Hypokalaemia

Epistaxis

Decreased appetite

Lymphopenia

Oedema

Vomiting

Alanine aminotransferase increased

Hypotension

Abdominal pain

Nasopharyngitis

Alanine Aminotransferase Increased

Hypertension

Rash

Abdominal Pain Upper

Hypophosphataemia

Influenza

Abdominal pain upper

Conjunctivitis

Muscle Spasms

Musculoskeletal Chest Pain

Muscle spasms

Aspartate aminotransferase increased

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (daratumumab)Experimental Treatment1 Intervention

Beginning 60-120 days after transplant, participants receive daratumumab IV over 4-8 hours on days 1, 8, 15 and 22 of courses 1 and 2 and days 1 and 15 of courses 3-6, then on day 1 of subsequent courses. Courses repeat every 28 days for 3 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab

2014

Completed Phase 3

~2380

0 / 14Eligibility criteria met