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Monoclonal Antibodies

SPd vs EloPd Chemotherapy for Multiple Myeloma

Phase 3
Recruiting
Research Sponsored by Stichting European Myeloma Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be able and willing to take enteric-coated aspirin according to clinical practice, or if history of prior thrombotic disease, must be fully anticoagulated with warfarin or be treated with full-dose, low molecular weight heparin
Received at least 1 and no more than 4 prior anti-MM lines of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to the date of disease progression or death (approximately up to 5 years)
Awards & highlights

Study Summary

This trial will compare two different chemotherapy regimens for multiple myeloma patients who have received one to four prior treatments. The first regimen contains the drugs pomalidomide, dexamethasone, and a monoclonal antibody. The second regimen contains the drugs elotuzumab, pomalidomide, and dexamethasone. The trial will measure efficacy, safety, and quality of life.

Who is the study for?
This trial is for adults with previously treated multiple myeloma who've had 1-4 prior treatments but haven't used selinexor, pomalidomide, or elotuzumab. They should have adequate organ function and no major health issues that could affect the study. People with certain infections or recent transplants can't join.Check my eligibility
What is being tested?
The trial compares two drug combinations: Selinexor, Pomalidomide, and Dexamethasone (SPd) versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd). It aims to see which combo is safer and more effective for treating multiple myeloma while also looking at how they impact quality of life.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, blood clots, liver problems, low blood counts leading to increased infection risk or bleeding tendencies. Specific drugs may cause unique side effects like nerve damage from Elotuzumab or weight changes due to Selinexor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take aspirin or am fully anticoagulated if I have a history of blood clots.
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I have had 1 to 4 treatments for my multiple myeloma.
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I might be using alternative blood thinners as decided by my doctor.
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My blood counts are within normal ranges as of last week.
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My multiple myeloma has returned or didn't respond to treatment and can be measured.
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I can take care of myself but might not be able to do heavy physical work.
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I haven't had a platelet transfusion in the last week.
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I had hepatitis C but was treated successfully and now have an undetectable viral load.
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I am a woman who can have children and have had two negative pregnancy tests before starting the study treatment.
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My side effects from previous treatments are mild as of the first treatment day.
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I have HIV with a CD4 count ≥350, no AIDS infections in the last year, and have been on ART for 4 weeks.
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My kidney function is normal as tested within the last 28 days.
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I haven't received blood cell growth support in the last 2 weeks.
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I haven't had a blood transfusion in the last 2 weeks.
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My liver is functioning well, as tested within the last 28 days.
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I am 18 years old or older.
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I have hepatitis B but have been on antiviral therapy for over 8 weeks and my viral load is under 100 IU/mL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to the date of disease progression or death (approximately up to 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to the date of disease progression or death (approximately up to 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Multiple Myeloma
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30) score and the difference between-treatment arms
Duration of response
+6 more

Side effects data

From 2015 Phase 2 trial • 36 Patients • NCT02011113
72%
NEUTROPENIA
47%
ANAEMIA
44%
THROMBOCYTOPENIA
25%
PYREXIA
25%
CONSTIPATION
25%
NASOPHARYNGITIS
22%
LYMPHOPENIA
19%
DIARRHOEA
19%
OEDEMA PERIPHERAL
19%
NAUSEA
19%
RASH
17%
LEUKOPENIA
17%
INSOMNIA
17%
MALAISE
14%
DYSGEUSIA
14%
PNEUMONIA
11%
FATIGUE
11%
DECREASED APPETITE
11%
HYPERURICAEMIA
11%
HYPOALBUMINAEMIA
11%
UPPER RESPIRATORY TRACT INFECTION
11%
HYPOKALAEMIA
11%
EPISTAXIS
8%
Pharyngitis
8%
HYPERGLYCAEMIA
8%
RASH MACULO-PAPULAR
8%
HYPOPHOSPHATAEMIA
8%
HYPOXIA
8%
ANXIETY
8%
MYALGIA
8%
HEPATIC FUNCTION ABNORMAL
8%
HERPES ZOSTER
6%
WEIGHT INCREASED
6%
CANCER PAIN
6%
HYPOTENSION
6%
HYPOGAMMAGLOBULINAEMIA
6%
ABDOMINAL PAIN UPPER
6%
HAEMORRHOIDS
6%
ASTHMA
6%
VOMITING
6%
DECUBITUS ULCER
6%
BRONCHITIS
6%
HYPERCALCAEMIA
6%
HYPOCALCAEMIA
6%
HYPONATRAEMIA
6%
HYPERSOMNIA
6%
PERIPHERAL SENSORY NEUROPATHY
6%
DYSPHONIA
6%
PLEURAL EFFUSION
6%
HICCUPS
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
CYSTITIS
6%
GASTROENTERITIS
6%
DIABETES MELLITUS
6%
RESTLESSNESS
6%
INCREASED APPETITE
6%
HEADACHE
6%
NEUROPATHY PERIPHERAL
6%
MUSCLE SPASMS
6%
WEIGHT DECREASED
6%
TREMOR
6%
HYPOTHYROIDISM
6%
SOMNOLENCE
6%
PROCTALGIA
6%
DYSPNOEA
3%
SEPSIS
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
MULTI-ORGAN FAILURE
3%
INTERSTITIAL LUNG DISEASE
3%
C-REACTIVE PROTEIN INCREASED
3%
CARDIAC FAILURE
3%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
3%
URINARY RETENTION
3%
MENINGITIS
3%
SPINAL COMPRESSION FRACTURE
3%
BLOOD FIBRINOGEN DECREASED
3%
BACK PAIN
3%
SHOCK HAEMORRHAGIC
3%
PNEUMONIA PNEUMOCOCCAL
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pomalidomide Plus Dexamethasone

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Selinexor, pomalidomide and dexamethasone (SPd)Experimental Treatment3 Interventions
Selinexor will be given as an oral dose: 40 mg (2 20 mg tablets) once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle. Pomalidomide will be given as an oral 4 mg dose QD on Days 1 to 21 of each 28-day cycle. Patients ≤75 years: o Dexamethasone will be given as an oral 40 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Dose may be divided over 2 days at the Investigator's discretion. Patients > 75 years: Dexamethasone will be given as an oral 20 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Dose may be divided over 2 days at the Investigator's discretion.
Group II: Elotuzumab, Pomalidomide and Dexamethasone (EloPd)Active Control3 Interventions
Elotuzumab will be given IV 10 mg/kg on Days 1, 8, 15, and 22 of cycle 1 and 2 then 20 mg/kg on Day 1 of cycles ≥3 of each 28-day cycle. Pomalidomide will be given as an oral 4 mg dose once a day (QD) on Days 1 to 21 of each 28-day cycle. Patients ≤75 years: Dexamethasone 28 mg PO + 8 mg IV on days of elotuzumab dosing Dexamethasone 40 mg PO on non-elotuzumab days (e.g., days 8, 15, and 22 of cycle 3 and beyond). Dose may be divided over 2 days at the Investigator's discretion. Patients >75 years: Dexamethasone 8 mg PO + 8 mg IV on days of elotuzumab dosing Dexamethasone 20 mg PO on non-elotuzumab dosing weeks (e.g., days 8, 15, and 22 of cycle 3 and beyond). Dose may be divided over 2 days at the Investigator's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone Oral
2020
N/A
~14110

Find a Location

Who is running the clinical trial?

Stichting European Myeloma NetworkLead Sponsor
27 Previous Clinical Trials
18,350 Total Patients Enrolled
21 Trials studying Multiple Myeloma
13,566 Patients Enrolled for Multiple Myeloma
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,357 Total Patients Enrolled
22 Trials studying Multiple Myeloma
1,998 Patients Enrolled for Multiple Myeloma
European Myeloma NetworkLead Sponsor
26 Previous Clinical Trials
12,350 Total Patients Enrolled
20 Trials studying Multiple Myeloma
7,566 Patients Enrolled for Multiple Myeloma

Media Library

Elotuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05028348 — Phase 3
Multiple Myeloma Research Study Groups: Elotuzumab, Pomalidomide and Dexamethasone (EloPd), Selinexor, pomalidomide and dexamethasone (SPd)
Multiple Myeloma Clinical Trial 2023: Elotuzumab Highlights & Side Effects. Trial Name: NCT05028348 — Phase 3
Elotuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05028348 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Pomalidomide a danger to patients?

"There is some evidence that Pomalidomide is effective, as this is a Phase 3 trial. Furthermore, multiple rounds of data support Pomalidomide's safety, leading to a score of 3."

Answered by AI

What diseases or conditions does Pomalidomide commonly help with?

"ophthalmia, sympathetic is often treated with Pomalidomide. However, Pomalidomide can also be used to ameliorate other issues such as macular edema, branch retinal vein occlusion, and communicable diseases."

Answered by AI

Can you give me a ballpark number of the hospitals participating in this research?

"There are 25 sites that are currently enrolling patients for this clinical trial. The sites are located in cities such as West Reading, Greenville, Winston-Salem and 25 other locations. It would be best to choose the location closest to you to reduce travel time and effort, if you do decide to participate."

Answered by AI

What other scientific investigations have used Pomalidomide as a research drug?

"First appearing in medical literature in 2002, pomalidomide has been studied in 1152 completed clinical trials. Of these, 629 are active and ongoing, with several originating from West Reading, Pennsylvania."

Answered by AI
~111 spots leftby Mar 2026