Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥18 years old)
Documented MM in relapse according to standard criteria.
All patients must have received between 1 to 3 prior therapies for MM (a prior therapy is defined as 2 or more cycles of therapy given as a MM treatment plan)
ICARIA schema: isatuximab, pomalidomide and dexamethasone.
Disqualifiers
Contraindications to investigational medicinal products or auxiliary medicinal product
Evidence of refractoriness or intolerance to anti-CD38 monoclonal antibodies.
Previous treatment according to the ICARIA schema with pomalidomide or IKEMA schema with carfilzomib
Allogenic hematopoietic cell transplant (HCT, regardless of timing).
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone
DrugICARIA schema : 40mg (20mg for ≥75yr) on day 1, 8, 15, 22 of each cycle plus IKEMA schema : 20 mg on day 1-2, day 8-9, day 15-16 and day 22-23 of each cycle For subjects older than 75 years or underweight (BMI \<18.5), the dexamethasone dose may be administered at a total dose of 20 mg weekly. In both schema (ICARIA or IKEMA), dexamethasone will be administrated up to 2 cycle (Arm 1) or until disease progression (Arm2)
Treatment groups
318 Participants
are divided into 2 treatment groupsGroup A: Dexamethasone-freeExperimental treatment 1 intervention
Group B: DexamethasoneNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
overall response rate (ORR).
Response rate will be evaluated according to the IMWG criteria, after six 28 days cycles of salvage therapy.
Time frame
At the end of Cycle 6 of salvage therapy (each cycle is 28 days)Secondary outcomes
1
best overall response rate (ORR)
Response rate will be evaluated according to the IMWG criteria, during or after the study treatment at the time of data cutoff. Patients will be followed every 4 weeks (with either a medical visit or only an outpatient blood test) until disease progression and then every 12 weeks until final 2 years.
Time frame
2 years2
Time To Progress (TTP)
Time To Progress defined as the duration from the date of randomization to progressive disease, according to the IMWG criteria
Time frame
2 years3
Progression free survival (PFS)
Progression free survival is defined as the duration from the date of randomization to either progressive disease, according to the IMWG critera or death, at 2 years after randomization.
Time frame
2 years4
Overall survival OS
which is defined as the time between randomization and death due to any cause. Patients, who die, regardless of the cause of death, will be considered to have had an event even if they were lost to follow-up for an extended time
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov