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Proteasome Inhibitor

Quadruple Drug Therapy for Multiple Myeloma

Phase 2

Waitlist Available

Led By Elizabeth O'Donnell, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Subject must have documented multiple myeloma satisfying the CRAB criteria and measurable disease

Subject must be at least 18 years of age

Must not have

Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs

Subject has contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an experimental drug combination for people with newly diagnosed multiple myeloma who are eligible for a stem cell transplant. The drugs involved are: Carfilzomib, Isatuximab, Lenalidomide, and Dexamethasone.

Who is the study for?

This trial is for adults with newly diagnosed multiple myeloma who meet specific health criteria and are eligible for a stem cell transplant. They must have measurable disease, be in relatively good physical condition (ECOG score of 0-2), and agree to use effective contraception. People can't join if they've had certain treatments for multiple myeloma before, active infections like HIV or hepatitis B/C, recent major surgery or radiation therapy, other medical conditions that could affect the study, or if they're pregnant.

What is being tested?

The trial is testing a new combination of drugs: Carfilzomib, Isatuximab, Lenalidomide, and Dexamethasone in people with multiple myeloma who can undergo a stem cell transplant. The goal is to see how well this experimental drug mix works against this type of cancer.

What are the potential side effects?

Possible side effects from these drugs include fatigue; increased risk of infection; blood clots; heart issues; allergic reactions; nerve damage leading to numbness or pain; digestive problems like nausea or diarrhea; and blood disorders such as low red cells causing anemia.

Eligibility Criteria

Inclusion Criteria

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

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I have multiple myeloma with symptoms or measurable disease.

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I am 18 years old or older.

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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 agree to use a condom during the trial.

Exclusion Criteria

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

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I do not have a stomach or bowel condition that affects how I absorb pills.

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I cannot take certain medications to prevent blood clots.

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I have been diagnosed with primary amyloidosis, MGUS, or smoldering multiple myeloma.

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I have undergone radiation therapy in the last 14 days.

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I have been diagnosed with Waldenström's disease or a similar condition with IgM M-protein without bone damage.

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I have COPD, persistent asthma, or had asthma in the last 2 years.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I am currently taking medication that affects how my body processes drugs.

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I have a serious heart condition.

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I am a man and plan to try for a child during the study.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I had major surgery less than 2 weeks ago or haven't fully recovered.

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My multiple myeloma is affecting the lining of my brain and spinal cord.

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I had cancer other than multiple myeloma within the last 5 years.

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I have plasma cell leukemia or POEMS syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months 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 Response (CR + Stringent CR) Rate

Secondary study objectives

Complete Response Rate in Patients Deferring Stem Cell Transplant

Complete Response Rate in Patients With Upfront Stem Cell Transplant

Minimal Residual Disease (MRD) Rate After 4 Cycles Induction Therapy

+5 more

Other study objectives

Body composition

Side effects data

From 2021 Phase 3 trial • 126 Patients • NCT03029234

62%

Anaemia

49%

Upper respiratory tract infection

49%

Platelet count decreased

39%

White blood cell count decreased

38%

Hypertension

35%

Hypokalaemia

30%

Neutrophil count decreased

28%

Lymphocyte count decreased

23%

Pneumonia

21%

Cough

19%

Blood creatinine increased

19%

Insomnia

18%

Pyrexia

17%

Hyperuricaemia

17%

Diarrhoea

16%

Hypocalcaemia

16%

Neutrophil count increased

16%

Hypoalbuminaemia

16%

Blood lactate dehydrogenase increased

15%

Blood pressure increased

15%

Blood uric acid increased

15%

Lung infection

14%

Blood bilirubin increased

14%

Hyperglycaemia

14%

White blood cell count increased

14%

Blood glucose increased

14%

Constipation

12%

Neutrophil percentage increased

12%

Blood urea increased

11%

Alanine aminotransferase increased

11%

Hypercalcaemia

11%

Hyponatraemia

10%

Bronchitis

10%

Blood potassium decreased

10%

Oedema peripheral

10%

Neuropathy peripheral

10%

Productive cough

10%

Aspartate aminotransferase increased

10%

Lymphocyte percentage decreased

Leukocytosis

Hypoproteinaemia

Influenza

Blood albumin decreased

Blood phosphorus increased

Peripheral swelling

Back pain

Hypophosphataemia

Mean cell volume increased

Prealbumin decreased

Bilirubin conjugated increased

Vomiting

Abdominal distension

Cataract

Nasopharyngitis

Hypoglycaemia

Gamma-glutamyltransferase increased

Thrombocytopenia

Hyperkalaemia

Hepatic function abnormal

Respiratory tract infection

Nausea

Vision blurred

Plasma cell myeloma

Acute kidney injury

Bone pain

Localised infection

Cardiac amyloidosis

Hypotension

Chronic kidney disease

Interstitial lung disease

Pleural effusion

Deep vein thrombosis

Obstructive airways disorder

Myelopathy

Organising pneumonia

Myolipoma

Neuralgia

Asthma

Lipoma

Cerebral ischaemia

Nerve compression

Disease progression

Infusion site extravasation

Escherichia sepsis

Otitis media

Periodontitis

Pathological fracture

Pain

Device related infection

Dysuria

Soft tissue infection

Spinal compression fracture

Cardiac failure acute

Supraventricular tachycardia

Bronchiolitis

Pancreatitis acute

100%

80%

60%

40%

20%

Study treatment Arm

Carfilzomib With Dexamethasone

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Maintenance-High RiskExperimental Treatment4 Interventions

Only patients that have achieved a partial response (PR) or better after induction therapy with or without stem cell transplant will continue on to maintenance therapy. The treatment participants will receive for maintenance will be based on the biological features (or cytogenetics) of participants myeloma and categorized into two groups: Standard-risk and High Risk. High Risk: subjects with high risk cytogenetics (deletion (del 17, translocation (t)(4:14), t(14;16), t(14;20), 1q duplications) will receive the following study treatment for up to two years (24 28-day cycles) until progressive disease (PD) or unacceptable toxicity: Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1

Group II: Maintenance- Standard RiskExperimental Treatment1 Intervention

Only patients that have achieved a partial response (PR) or better after induction therapy with or without stem cell transplant will continue on to maintenance therapy. The treatment participants will receive for maintenance will be based on the biological features (or cytogenetics) of participants myeloma and categorized into two groups: Standard-risk and High Risk. Standard Risk: subjects without high risk cytogenetics (deletion (del 17, translocation (t)(4:14), t(14;16), t(14;20), 1q duplications) will receive the following study treatment for up to two years (24 28-day cycles) until progressive disease (PD) or unacceptable toxicity: - Lenalidomide 10 mg orally (PO) Day 1-21

Group III: InductionExperimental Treatment4 Interventions

All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.) For patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation). For patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles. Carfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Carfilzomib

2017

Completed Phase 3

~1430