What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, particularly those targeting CD38-positive myeloma cells like Isatuximab, include daratumumab and elotuzumab. These treatments are associated with higher rates of infections, including pneumonia, and neutropenia. Daratumumab recipients have shown increased overall infection rates and severe lymphocytopenia, which can lead to viral reactivations and fungal infections. Elotuzumab has been linked to higher rates of lymphocytopenia and herpes zoster. Isatuximab treatment often results in significant neutropenia and respiratory infections. These side effects highlight the need for careful monitoring and management of infections in patients undergoing these therapies.

What prior FDA approvals exist?

Isatuximab, which targets and kills CD38-positive myeloma cells, is similar to Daratumumab, another monoclonal antibody that also targets CD38 and has been FDA-approved for multiple myeloma. Both drugs are used in combination with other agents like pomalidomide and dexamethasone for relapsed or refractory multiple myeloma. Other FDA-approved treatments for multiple myeloma include Bortezomib, Lenalidomide, and Carfilzomib, which are proteasome inhibitors and immunomodulatory drugs, respectively. These treatments are often used in various combinations to enhance efficacy and manage the disease.

What other types of research exist?

Promising novel alternatives to Isatuximab for Multiple Myeloma patients include Daratumumab (another anti-CD38 monoclonal antibody), Elotuzumab (targets SLAMF7), and B-cell maturation antigen (BCMA)-targeted therapies such as Belantamab mafodotin and CAR T-cell therapies like Idecabtagene vicleucel and Ciltacabtagene autoleucel. These treatments have shown significant efficacy in clinical trials and are considered advanced options for relapsed or refractory Multiple Myeloma.

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Alkylating agents

Isatuximab + Bendamustine + Prednisone for Multiple Myeloma

Phase 1

Waitlist Available

Led By Ravi Vij, M.D.

Research Sponsored by Washington University School of Medicine

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 up to 5 years after removal from study (estimated to be 5 years and 6 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new combination of three drugs—isatuximab, bendamustine, and prednisone—for patients with multiple myeloma that has come back or didn't respond to previous treatments. The goal is to find the best dose and see how well this combination works. Isatuximab helps the immune system kill cancer cells, bendamustine damages cancer cell DNA, and prednisone reduces inflammation.

Who is the study for?

This trial is for adults with multiple myeloma that's hard to treat and has come back after other treatments. They should have measurable signs of the disease, be in fairly good health, and not pregnant or breastfeeding. They must agree to use birth control and sign a consent form. People who've had certain other cancers, serious illnesses, or specific treatments can't join.

What is being tested?

Researchers are testing a new combo treatment for tough cases of multiple myeloma using Isatuximab (targets cancer cells), Bendamustine (chemotherapy), and Prednisone (steroid). First they'll find the highest dose people can take without bad side effects, then see how well it works.

What are the potential side effects?

Possible side effects include reactions where the drug enters the body, low blood counts leading to higher infection risk or bleeding problems, nausea, fatigue, allergic reactions to ingredients in the drugs like sucrose or polysorbate 80.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment through 30 days after completion of treatment or initiation of new anti-myeloma therapy, whichever occurs first (estimated to be 7 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment through 30 days after completion of treatment or initiation of new anti-myeloma therapy, whichever occurs first (estimated to be 7 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment through 30 days after completion of treatment or initiation of new anti-myeloma therapy, whichever occurs first (estimated to be 7 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

Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of regimen (Phase I only)

Overall response rate (ORR) (Phase II only)

Secondary study objectives

Number of adverse events experienced by participants (Phase I and Phase II)

Overall survival (OS) (Phase II only)

Progression-free survival (PFS) (Phase II only)

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

Dyspnoea

Insomnia

Nausea

Urinary Tract Infection

Bone Pain

Cough

Nasopharyngitis

Peripheral Sensory Neuropathy

Cataract

Pruritus

Fall

Headache

Hypertension

Disease Progression

Decreased Appetite

Tremor

Muscular Weakness

Musculoskeletal Chest Pain

Rash

Acute Kidney Injury

Influenza

Abdominal Pain

Vomiting

Pneumocystis Jirovecii Pneumonia

Febrile Neutropenia

Pathological Fracture

Oropharyngeal Pain

Myalgia

Pain In Extremity

Septic Shock

Dizziness

Stomatitis

Renal Failure

Lower Respiratory Tract Infection

Hypercalcaemia

General Physical Health Deterioration

Oral Herpes

Productive Cough

Lung Infection

Pleural Effusion

Haemorrhage Intracranial

Pulmonary Embolism

Infusion Related Reaction

Renal Aneurysm

Sudden Death

Pneumonia Fungal

Covid-19 Pneumonia

Candida Pneumonia

Diverticulitis

Escherichia Sepsis

Cytomegalovirus Gastrointestinal Infection

Gastroenteritis

Tumour Associated Fever

Syncope

Dehydration

Respiratory Tract Infection

Basal Cell Carcinoma

Anaemia

Hyponatraemia

Confusional State

Malnutrition

Cerebral Haemorrhage

Angina Pectoris

Cauda Equina Syndrome

Ischaemic Stroke

Atrial Fibrillation

Cardiac Failure

Orthostatic Hypotension

Pulmonary Oedema

Respiratory Failure

Pancreatitis Acute

Diabetic Ulcer

Death

Accidental Overdose

Spinal Compression Fracture

Weight Decreased

Pneumonia Bacterial

Pyelonephritis

Pyelonephritis Acute

Sepsis

Sinusitis

Hyperviscosity Syndrome

Pancytopenia

Femur Fracture

Pneumonia Haemophilus

Pneumonia Influenzal

Pneumonia Streptococcal

Bronchospasm

Large Intestine Perforation

Covid-19

Infection

Presyncope

Spinal Subdural Haematoma

Retinal Detachment

Vision Blurred

Myocardial Infarction

Deep Vein Thrombosis

Ataxia

100%

80%

60%

40%

20%

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

4Treatment groups

Experimental Treatment

Group I: Phase II: Isatuximab + Bendamustine + PrednisoneExperimental Treatment3 Interventions

-Isatuximab (10 mg/kg) on Days 1, 8, 15, and 22 during Cycle 1 and on Days 1 and 15 of subsequent cycles. Bendamustine (dose determined in Phase I portion of study) will be administered on Days 1 and 2 and prednisone (60 mg) will be administered on Days 1 through 4 of each cycle.

Group II: Phase I Dose Level 3: Isatuximab + Bendamustine + PrednisoneExperimental Treatment3 Interventions

-Isatuximab (10 mg/kg) on Days 1, 8, 15, and 22 during Cycle 1 and on Days 1 and 15 of subsequent cycles. Bendamustine (100 mg/m\^2) will be administered on Days 1 and 2 and prednisone (60 mg) will be administered on Days 1 through 4 of each cycle.

Group III: Phase I Dose Level 2: Isatuximab + Bendamustine + PrednisoneExperimental Treatment3 Interventions

-Isatuximab (10 mg/kg) on Days 1, 8, 15, and 22 during Cycle 1 and on Days 1 and 15 of subsequent cycles. Bendamustine (75 mg/m\^2) will be administered on Days 1 and 2 and prednisone (60 mg) will be administered on Days 1 through 4 of each cycle.

Group IV: Phase I Dose Level 1: Isatuximab + Bendamustine + PrednisoneExperimental Treatment3 Interventions

-Isatuximab (10 mg/kg) on Days 1, 8, 15, and 22 during Cycle 1 and on Days 1 and 15 of subsequent cycles. Bendamustine (50 mg/m\^2) will be administered on Days 1 and 2 and prednisone (60 mg) will be administered on Days 1 through 4 of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Isatuximab

2016

Completed Phase 3

~370

Bendamustine

2015

Completed Phase 3

~3230

Prednisone

2014

Completed Phase 4

~2500

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple Myeloma include monoclonal antibodies like Isatuximab and Daratumumab, which target and kill CD38-positive myeloma cells, and proteasome inhibitors like Bortezomib, which disrupt protein degradation in cancer cells, leading to cell death. Immunomodulatory drugs such as Lenalidomide enhance the immune system's ability to fight cancer. These treatments are crucial for Multiple Myeloma patients as they target specific pathways and proteins involved in the growth and survival of myeloma cells, thereby improving survival rates and quality of life.

Complement and cellular cytotoxicity in antibody therapy of cancer.