About this trial
This is a multi-institution, open label, phase I/II study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible MM.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented newly diagnosed multiple myeloma
Patient should be deemed transplant eligible.
Patients may not have had more than 1 cycle of prior induction therapy. If a patient has had 1 cycle of prior multiple myeloma therapy, the patient must have had documented measurable disease prior to initiation of cycle 1.
Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Disqualifiers
Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
Subject has any condition that confounds the ability to interpret data from the study
Subject has nonsecretory multiple myeloma
Trial design
Single group
Treatments tested in this trial
Carfilzomib
Drug20 mg/m2 C1D1; 56 mg/m2 thereafter
Iberdomide
DrugOral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle
Oral Dexamethasone
Drug40 mg (\<=75 years old); 20 mg (\>75 years old)
Treatment groups
Trial outcomes
Primary outcomes
Rate of treatment emergent adverse events (TEAEs)
Rate of patients with treatment emergent adverse events (TEAEs) overall and per dose level
CR and sCR
Evaluation of the rate of complete remission (CR) + stringent complete (sCR) remission for patients receiving 2-4 cycles of the combination of KID followed by ASCT in patients with newly diagnosed MM.
Secondary outcomes
Overall Response Rate (ORR)
Assessment of overall response rate (ORR) of newly diagnosed transplant-eligible MM patients.
Progression Free Survival (PFS)
Assessment of progression-free survival (PFS) of newly diagnosed transplant-eligible MM patients.
Overall Survival (OS)
Assessment of overall survival (OS) of newly diagnosed transplant-eligible MM patients.
Sponsors and contacts
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