Actively Recruiting
Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-12-18
318
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with relapsed/refractory symptomatic multiple myeloma who meet all inclusion criteria, will be randomized 1:1 to receive either standard of care chemotherapy (IKEMA or ICARIA) and dexamethasone until disease progression ("dexamethasone arm", arm A) or standard of care chemotherapy (IKEMA or ICARIA) and dexamethasone with dexamethasone discontinuation from the 3rd cycle of treatment (after 8 weeks) ("dexamethasone-free arm", arm B). In most centers, IKEMA and ICARIA schema can be adapted according to the standard of care in each center Choice between the ICARIA and IKEMA schema is at the discretion of the investigator, in compliance with each drug's SmPC, but must be performed before randomisation for the purpose of stratification.
CONDITIONS
Official Title
Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years old or older)
- Documented multiple myeloma in relapse according to standard criteria
- Received between 1 to 3 prior therapies for multiple myeloma (each prior therapy involves 2 or more cycles)
- Eligible for either ICARIA (isatuximab, pomalidomide, dexamethasone) or IKEMA (isatuximab, carfilzomib, dexamethasone) treatment
- Achieved a response (partial response or better) to the prior treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Toxicities from previous therapy (including peripheral neuropathy) have resolved or stabilized
- Signed informed consent
You will not qualify if you...
- Contraindications to the investigational or auxiliary medicinal products
- Refractoriness or intolerance to anti-CD38 monoclonal antibodies
- Prior treatment with ICARIA regimen including pomalidomide or IKEMA regimen including carfilzomib
- History of allogenic hematopoietic cell transplant
- Planned hematopoietic cell transplant before disease progression
- History of other malignancies within 3 years before randomization, except certain skin cancers or cured malignancies with minimal recurrence risk
- Known meningeal involvement of multiple myeloma
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or amyloidosis
- Any concurrent medical condition likely to interfere with study procedures or pose a hazard
- Uncontrolled chronic obstructive pulmonary disease (COPD)
- Clinically significant heart disease
- Positive hepatitis B PCR test
- Positive for HIV or hepatitis C
- Lactating women
- Participation in another interventional clinical trial
- Unable to provide written informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Service d'hématologie clinique et thérapie cellulaire, Saint-Antoine Hospital
Paris, France, 75012
Actively Recruiting
Research Team
M
Mohamad MOHTY, PU-PH
CONTACT
F
Florent MALARD, PU-PH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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