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Monoclonal Antibodies

Isatuximab + Dexamethasone + Lenalidomide for Multiple Myeloma (UltraFrailMM Trial)

Phase 2
Waitlist Available
Led By Ghulam Rehman Mohyuddin, MBBS
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Known prior severe hypersensitivity (NCI CTCAE v5.0 Grade ≥ 3) to investigational product (IP) or any component in its formulations. This includes hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents
Subjects currently taking prohibited medications as described in the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion. participants will be enrolled in study for about 3 years.
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study a new approach for treating very frail patients with multiple myeloma. The researchers believe that starting treatment slowly and gently, with a combination of Isatuximab and d

Who is the study for?
This trial is for ultra-frail patients with multiple myeloma who often have difficulty tolerating standard treatments. It's designed to test if starting treatment slowly improves their ability to stick with the therapy and enhances their quality of life.
What is being tested?
The study tests a 'go-slow' approach using Isatuximab and Dexamethasone initially, then gradually introducing Lenalidomide from the third cycle onwards. The aim is to see if this method reduces early treatment mortality and increases adherence in frail patients.
What are the potential side effects?
Potential side effects may include reactions related to Isatuximab such as infusion-related symptoms, low blood counts from Dexamethasone, and possible digestive issues or fatigue when Lenalidomide is introduced.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am severely allergic to certain drugs or ingredients used in this study.
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I am not taking any medications that are not allowed in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion. participants will be enrolled in study for about 3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at study completion. participants will be enrolled in study for about 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
Completion rate of 9 cycles of treatment
Secondary study objectives
Change in quality of life as per the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 domain
Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration
Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment
+4 more

Side effects data

From 2023 Phase 3 trial • 307 Patients • NCT02990338
35%
Neutropenia
21%
Diarrhoea
21%
Fatigue
21%
Pneumonia
20%
Constipation
19%
Asthenia
19%
Upper Respiratory Tract Infection
16%
Back Pain
13%
Pyrexia
12%
Arthralgia
12%
Oedema Peripheral
11%
Bronchitis
11%
Thrombocytopenia
11%
Muscle Spasms
9%
Dyspnoea
9%
Insomnia
9%
Nausea
9%
Urinary Tract Infection
9%
Bone Pain
7%
Cough
7%
Nasopharyngitis
7%
Peripheral Sensory Neuropathy
7%
Cataract
7%
Pruritus
6%
Fall
6%
Headache
5%
Hypertension
5%
Disease Progression
5%
Decreased Appetite
5%
Tremor
5%
Muscular Weakness
5%
Musculoskeletal Chest Pain
5%
Rash
4%
Acute Kidney Injury
4%
Influenza
4%
Abdominal Pain
4%
Vomiting
3%
Pneumocystis Jirovecii Pneumonia
3%
Febrile Neutropenia
3%
Pathological Fracture
3%
Oropharyngeal Pain
3%
Myalgia
3%
Pain In Extremity
3%
Septic Shock
3%
Dizziness
3%
Stomatitis
2%
Renal Failure
2%
Lower Respiratory Tract Infection
2%
Hypercalcaemia
2%
General Physical Health Deterioration
2%
Oral Herpes
2%
Productive Cough
2%
Lung Infection
1%
Pleural Effusion
1%
Haemorrhage Intracranial
1%
Infusion Related Reaction
1%
Pulmonary Embolism
1%
Renal Aneurysm
1%
Sudden Death
1%
Pneumonia Fungal
1%
Covid-19 Pneumonia
1%
Candida Pneumonia
1%
Diverticulitis
1%
Escherichia Sepsis
1%
Cytomegalovirus Gastrointestinal Infection
1%
Gastroenteritis
1%
Tumour Associated Fever
1%
Syncope
1%
Dehydration
1%
Respiratory Tract Infection
1%
Basal Cell Carcinoma
1%
Anaemia
1%
Hyponatraemia
1%
Confusional State
1%
Malnutrition
1%
Cerebral Haemorrhage
1%
Angina Pectoris
1%
Cauda Equina Syndrome
1%
Ischaemic Stroke
1%
Atrial Fibrillation
1%
Cardiac Failure
1%
Orthostatic Hypotension
1%
Pulmonary Oedema
1%
Respiratory Failure
1%
Pancreatitis Acute
1%
Diabetic Ulcer
1%
Death
1%
Accidental Overdose
1%
Spinal Compression Fracture
1%
Weight Decreased
1%
Pneumonia Bacterial
1%
Pyelonephritis
1%
Pyelonephritis Acute
1%
Sepsis
1%
Sinusitis
1%
Hyperviscosity Syndrome
1%
Pancytopenia
1%
Femur Fracture
1%
Pneumonia Haemophilus
1%
Pneumonia Influenzal
1%
Pneumonia Streptococcal
1%
Bronchospasm
1%
Large Intestine Perforation
1%
Covid-19
1%
Infection
1%
Presyncope
1%
Spinal Subdural Haematoma
1%
Retinal Detachment
1%
Vision Blurred
1%
Myocardial Infarction
1%
Deep Vein Thrombosis
1%
Ataxia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pd (Pomalidomide + Dexamethasone)
IPd (Isatuximab + Pomalidomide + 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: Combination TreatmentExperimental Treatment1 Intervention
Isatuximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
2016
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,140 Previous Clinical Trials
1,697,690 Total Patients Enrolled
7 Trials studying Multiple Myeloma
276 Patients Enrolled for Multiple Myeloma
SanofiIndustry Sponsor
2,204 Previous Clinical Trials
4,036,738 Total Patients Enrolled
49 Trials studying Multiple Myeloma
9,766 Patients Enrolled for Multiple Myeloma
Ghulam Rehman Mohyuddin, MBBSPrincipal InvestigatorHuntsman Cancer Institute
~27 spots leftby Nov 2026
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