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Corticosteroid
Isatuximab + Lenalidomide + Dexamethasone for Multiple Myeloma (ITHACA Trial)
Phase 3
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or 2
Capable of giving voluntary written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to follow-up (up to approximately 7 years)
Awards & highlights
ITHACA Trial Summary
This trial is testing a drug to see if it can help people with a certain type of cancer.
Who is the study for?
This trial is for people diagnosed within the last 5 years with high-risk smoldering multiple myeloma (SMM), which means they have certain levels of M-protein and bone marrow plasma cells but no severe symptoms. They should be able to perform daily activities with ease or with some limitations (ECOG Performance Status 0-2).Check my eligibility
What is being tested?
The study tests if adding Isatuximab to Lenalidomide and Dexamethasone can prolong the time patients live without their disease getting worse, compared to just Lenalidomide and Dexamethasone. It's a Phase 3 trial where one group gets all three drugs, while another gets only two.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, increased risk of infections due to low blood cell counts, fatigue, digestive issues like constipation or diarrhea, and potential allergic reactions.
ITHACA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I can sign the consent form on my own.
Select...
I was diagnosed with high-risk smoldering multiple myeloma within the last 5 years.
ITHACA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to follow-up (up to approximately 7 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to follow-up (up to approximately 7 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Plasma concentration of isatuximab: Cmax- Safety Run-in Part
Progression-free survival (PFS) Randomized Phase 3
Receptor density/receptor occupancy Safety Run-in Part
+1 moreSecondary outcome measures
Complete response rate - Randomized Phase 3
Duration of response (DOR)-Safety Run-in Part and Randomized Phase 3
EORTC QLQ-MY20 - Randomized Phase 3
+16 moreSide effects data
From 2023 Phase 1 & 2 trial • 351 Patients • NCT0108425250%
Fatigue
38%
Anaemia
31%
Infusion Related Reaction
31%
Headache
25%
Nausea
25%
Chills
25%
Pyrexia
19%
Cough
19%
Diarrhoea
13%
Contusion
13%
Oedema Peripheral
13%
Vision Blurred
13%
Hypercalcaemia
13%
Thrombocytopenia
13%
Vomiting
13%
Urinary Tract Infection
13%
Blood Creatinine Increased
13%
Lymphocyte Count Decreased
13%
Bone Pain
13%
Pain In Extremity
13%
Dysgeusia
13%
Dyspnoea
6%
Pain
6%
Upper Respiratory Tract Infection
6%
Groin Pain
6%
Herpes Simplex
6%
Dizziness
6%
Sinusitis
6%
Back Pain
6%
Abnormal Dreams
6%
Abdominal Pain
6%
Abdominal Pain Upper
6%
Gastrointestinal Pain
6%
Otitis Media
6%
Myelodysplastic Syndrome
6%
Meningitis Bacterial
6%
Constipation
6%
Acute Kidney Injury
6%
Bradycardia
6%
Glossodynia
6%
Stomatitis
6%
Respiratory Tract Infection
6%
Balance Disorder
6%
Dry Mouth
6%
Gastrooesophageal Reflux Disease
6%
Disease Progression
6%
Influenza Like Illness
6%
Malaise
6%
Cytokine Release Syndrome
6%
Bronchitis
6%
Limb Discomfort
6%
Muscle Spasms
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Head Discomfort
6%
Peripheral Sensory Neuropathy
6%
Agitation
6%
Bradyphrenia
6%
Depression
6%
Insomnia
6%
Irritability
6%
Productive Cough
6%
Throat Lesion
6%
Dermatitis Contact
6%
Hypertension
6%
Onychoclasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Isatuximab 1mg/kg Q2W
Phase 1: Isatuximab 20mg/kg QW
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Phase 1: Isatuximab 3mg/kg Q2W
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Phase 1: Isatuximab 20mg/kg Q2W
Phase 2 Stage 2: Isatuximab Alone
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Phase 1: Isatuximab 5mg/kg Q2W
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Phase 2 Stage 2: Isatuximab + Dexamethasone
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Phase 1: Isatuximab 10mg/kg QW
ITHACA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Isatuximab, lenalidomide, and dexamethasone (ILd)Experimental Treatment7 Interventions
Participants will receive isatuximab [intravenous (IV) administration] in combination with lenalidomide [per os (PO) administration] and dexamethasone [IV on Day 1 of Cycle 1 for participants receiving isatuximab IV only and PO otherwise for subsequent cycles] for 24 cycles followed by isatuximab monotherapy for 12 cycles for a total duration of 36 cycles. 1 cycle = 28 days. Participants may receive other treatments as pre-medication.
Group II: Lenalidomide and dexamethasone (Ld)Active Control2 Interventions
Lenalidomide [PO administration] in combination with dexamethasone [PO administration] for 24 cycles. 1 cycle = 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone or equivalent
2007
Completed Phase 4
~50
Acetaminophen
2017
Completed Phase 4
~2030
Isatuximab SAR650984
2015
Completed Phase 2
~580
Lenalidomide
2005
Completed Phase 3
~1480
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,143 Total Patients Enrolled
47 Trials studying Multiple Myeloma
9,864 Patients Enrolled for Multiple Myeloma
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,962 Total Patients Enrolled
22 Trials studying Multiple Myeloma
3,866 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine within 4 weeks before starting the study drug, except for the seasonal flu shot.I can sign the consent form on my own.I do not have conditions that affect how my body absorbs medication.I can take care of myself and am up and about more than half of my waking hours.I agree to use effective birth control during the study.I was diagnosed with high-risk smoldering multiple myeloma within the last 5 years.I have been treated for SMM or MM but am not currently on bisphosphonates or denosumab.You have an ongoing hepatitis C virus infection with a positive HCV RNA test and a negative anti-HCV test.I do not have serious heart problems or recent heart attacks.My condition involves symptoms like high calcium, kidney issues, anemia, or bone problems due to myeloma.I haven't had severe stomach issues, bowel diseases, or serious blood clots in the last 3 months.You have an ongoing, uncontrolled HBV infection with positive HBsAg and/or HBV DNA.I have been treated for cancer within the last 3 years.I am currently taking more than 10 mg of prednisone or its equivalent daily.I do not have AIDS, HIV needing treatment, or active hepatitis A.
Research Study Groups:
This trial has the following groups:- Group 1: Isatuximab, lenalidomide, and dexamethasone (ILd)
- Group 2: Lenalidomide and dexamethasone (Ld)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people can sign up for this research project?
"The listed clinicaltrials.gov entry for this study confirms that it is actively recruiting patients. This research, which was first advertised on June 16th 2020, will enroll 300 individuals from 23 different locations."
Answered by AI
What are the primary indications for Isatuximab SAR650984?
"Isatuximab SAR650984 is most commonly used to treat sympathetic ophthalmia. It can also be used as a last resort for conditions such as at least two prior systemic chemotherapy regimens, branch retinal vein occlusion, and macular edema."
Answered by AI
How many different facilities are responsible for this research?
"The primary locations for this study are University of Texas - MD Anderson Cancer Center-Site Number:8400002 in Houston, Texas; Novant Health Forsyth Medical Center-Site Number:8401015 in Winston-Salem, North carolina; and BIDMC-Site Number:8400008 in Boston, Massachusetts. Additionally, there are 23 other sites participating."
Answered by AI
Could you please share if this research project is looking for more participants?
"That is correct, the clinicaltrials.gov website has this information available and easy to find. The study was originally posted on June 16th, 2020 with the most recent update being October 14th, 2022. They are looking for 300 patients that will be spread out across 23 different sites."
Answered by AI
What is the side effect profile of Isatuximab SAR650984?
"Since Isatuximab SAR650984 is in Phase 3 trials, there is both efficacy and safety data available. This led our team to rate the medication a 3 on our Power scale."
Answered by AI
Are there any precedents for the use of Isatuximab SAR650984 in medical research?
"The first recorded study of Isatuximab SAR650984 took place in 2002 at the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. As of now, there have been a total of 1,350 completed studies with 741 clinical trials still ongoing. A large number of these active trials are based in Houston, Texas."
Answered by AI
What are the goals of this research?
"The purpose of this study is to evaluate the efficacy of isatuximab over a period of up to 85 months. The primary outcome measure will be the maximum plasma concentration (Cmax) of isatuximab, and secondary measures include sustained MRD negativity (defined as persistence of negative results on at least one assessment 1 year after initial negativity), plasma concentration of isatuximab (Cmax), and EQ-5D-5L scores."
Answered by AI
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