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Monoclonal Antibodies

Selinexor + DRd for Multiple Myeloma

Phase 2

Recruiting

Led By Robert M Rifkin, MD, FACP

Research Sponsored by US Oncology Research

Eligibility Criteria Checklist

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

Must have

At least 18 years of age

Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

Must not have

Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma

Has certain specific medical conditions such as plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or amyloid light-chain amyloidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of selinexor in combination with daratumumab, lenalidomide, and dexamethasone as a first-line treatment for multiple myeloma.

Who is the study for?

Adults with untreated multiple myeloma can join this trial. They must be able to follow the study plan and use effective birth control if they can have children. People who've had major surgery recently, have brain involvement by myeloma, HIV, hepatitis B or C, serious heart issues, or certain blood conditions cannot participate.

What is being tested?

The trial is testing a combination of four drugs: Selinexor plus Daratumumab, Lenalidomide, and Dexamethasone (S-DRd) as a first-line treatment for multiple myeloma. It's an open-label phase II study where everyone gets the same treatment.

What are the potential side effects?

Possible side effects include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems; some may experience nerve damage or changes in liver function tests.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am able to care for myself and perform daily activities.

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My myeloma has not been treated before.

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I am not pregnant and agree to use effective birth control.

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My condition is officially diagnosed as multiple myeloma.

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I am a man and use effective birth control methods if sexually active.

Exclusion Criteria

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

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My multiple myeloma has affected my brain or spinal cord.

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I have a specific condition like plasma cell leukemia or Waldenström's.

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I am eligible for a stem cell transplant.

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I have a serious heart condition.

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I haven't had major surgery in the last 2 weeks and don't plan any during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Safety of Selinexor plus DRd

Stringent Complete Response Rate (sCR)

Secondary study objectives

Duration of Response

Minimal Residual Disease (MRD)

Objective Response Rate (ORR)

+3 more

Side effects data

From 2022 Phase 3 trial • 402 Patients • NCT03110562

50%

Thrombocytopenia

45%

Anaemia

39%

Nausea

29%

Decreased appetite

29%

Diarrhoea

27%

Weight decreased

24%

Neuropathy peripheral

24%

Vomiting

23%

Fatigue

21%

Neutropenia

21%

Cataract

15%

Asthenia

12%

Upper respiratory tract infection

11%

Pyrexia

11%

Constipation

Oedema peripheral

Pneumonia

Lymphopenia

Dizziness

Insomnia

Dehydration

Back pain

Leukopenia

Bronchitis

Cough

Acute kidney injury

Abdominal pain

Muscular weakness

Lower respiratory tract infection

Pain in extremity

Sepsis

Hyperglycaemia

Urinary tract infection

Nasopharyngitis

Hyponatraemia

Toothache

Disturbance in attention

Cardiac failure

Hypertension

Embolism

Peripheral swelling

Haemoglobin decreased

Blood uric acid increased

Cardiac failure acute

Pulmonary contusion

Blood creatinine increased

Paraesthesia

Infection

Respiratory syncytial virus infection

Dyspepsia

Syncope

Clostridium difficile infection

Compression fracture

Multiple fractures

Myocardial infarction

C-reactive protein increased

Cerebral haemorrhage

Ischaemic stroke

Sudden death

Oropharyngeal pain

Cognitive disorder

Confusional state

Influenza

Septic shock

Osteonecrosis of jaw

Taste disorder

Hyperkalaemia

Depression

Cerebrovascular accident

Bronchitis viral

100%

80%

60%

40%

20%

Study treatment Arm

SVdX Arm: Selinexor + Bortezomib + Dexamethasone

SdX Arm: Selinexor + 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: Selinexor plus DRdExperimental Treatment4 Interventions

1. Lenalidomide 15 mg orally on Days 1-21 of each 28-day cycle 2. Dexamethasone 40 mg on Days 1, 8, 15, 22 of each cycle. However, those \>75 years old may be administered a weekly dose of 20 mg dexamethasone. 3. Daratumumab 1800 mg subcutaneous injection once weekly in Cycles 1 and 2, every 2 weeks in cycles 3 to 6, and every 4 weeks thereafter. 4. Selinexor 60 mg on Days 1, 8, 15, of cycles 1-3, with a planned dose-reduction to 40 mg on Days 1, 8, 15 for cycles beyond 3. If patient was previously dose reduced prior to cycle 4, then at cycle 4 planned dose reduction, you will again decrease dose by 1 level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab

2014

Completed Phase 3

~2380

Lenalidomide

2005

Completed Phase 3

~2240