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Anti-tumor antibiotic

Drug Combination for Relapsed Multiple Myeloma

Phase 2

Waitlist Available

Led By Andrew J Yee, 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a mix of drugs to see if they can help treat Multiple Myeloma that has come back after treatment or has not responded to treatment. The drugs being studied are elotuz

Who is the study for?

This trial is for adults over 18 with relapsed Multiple Myeloma who have had at least one prior therapy including lenalidomide and a proteasome inhibitor. Participants must have measurable disease indicators, such as specific levels of monoclonal protein in blood or urine, and be physically able to perform daily activities (ECOG ≤ 2).

What is being tested?

The study tests a combination treatment for Multiple Myeloma using Elotuzumab, Pomalidomide, Bortezomib, and Dexamethasone. It aims to find out how effective this drug mix is for those whose cancer has returned after previous treatments.

What are the potential side effects?

Potential side effects may include immune system reactions, fatigue, nausea, nerve damage causing pain or numbness (neuropathy), increased risk of infections due to low blood cell counts, and possible steroid-related issues like mood swings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Overall response rate by International Myeloma Working Group criteria.

Secondary study objectives

Progression Free Survival

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562

43%

Weight decreased

29%

Decreased appetite

29%

Cough

29%

Thrombocytopenia

29%

Nausea

21%

Fatigue

21%

Anaemia

21%

Constipation

21%

Diarrhoea

14%

Neuropathy peripheral

14%

Oedema peripheral

14%

Pneumonia

14%

Paraesthesia

14%

Cataract

14%

Vomiting

14%

Headache

Urinary tract infection

Bronchiectasis

Hyperthyroidism

Asthma

Disturbance in attention

Respiratory syncytial virus infection

Neutropenia

Peripheral swelling

Mental status changes

Lower respiratory tract infection

Back pain

Pain in extremity

Basal cell carcinoma

Hyponatraemia

Skin lesion

Oropharyngeal pain

Pyrexia

Cardiac failure

Hepatitis

Pharyngitis

Hypophagia

Pollakiuria

Non-cardiac chest pain

C-reactive protein increased

Taste disorder

Haemorrhagic transformation stroke

Abdominal pain

Insomnia

Dyspepsia

Haemoglobin decreased

Infection

Hyperglycaemia

Toothache

Ecchymosis

Upper respiratory tract infection

Nasopharyngitis

Fungal skin infection

Viral infection

Hypertension

Muscular weakness

100%

80%

60%

40%

20%

Study treatment Arm

SdX Arm: Selinexor + Dexamethasone

SVdX Arm: Selinexor + Bortezomib + Dexamethasone

SVd Arm: Selinexor + Bortezomib + Dexamethasone

Vd Arm: Bortezomib + Dexamethasone

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: Elotuzumab, pomalidomide, bortezomib, dexExperimental Treatment4 Interventions

Each cycle is 28 days. Elotuzumab will be administered by intravenous infusion. For cycles 1-2, elotuzumab will ge given weekly. For cycles 3-8, elotuzumab will be given every other week. For cycles 9+, elotuzumab will be given on day 1. Pomalidomide will be given orally on days 1-21. Bortezomib will be given weekly subcutaneously on days 1, 8, 15. Dexamethasone will be given as a combination orally and intravenously.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elotuzumab

2016

Completed Phase 3

~910

Pomalidomide

2011

Completed Phase 2

~1020