Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Transplant Eligible Multiple Myeloma

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHackensack Meridian Health

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Carfilzomib

    Drug

    20 mg/m2 C1D1; 56 mg/m2 thereafter

  • Iberdomide

    Drug

    Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle

  • Oral Dexamethasone

    Drug

    40 mg (\<=75 years old); 20 mg (\>75 years old)

Treatment groups

66 Participants
are divided into 4 treatment groups
Group A: Starting Dose -1Experimental treatment 3 interventions
Group B: Dose Level 1Experimental treatment 3 interventions
Group C: Dose Level 2Experimental treatment 3 interventions
Group D: Dose Level -2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Rate of treatment emergent adverse events (TEAEs)

Rate of patients with treatment emergent adverse events (TEAEs) overall and per dose level

Time frame
Measured after cycle 4 of induction KID (each cycle is 28 days)
2

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.

Time frame
Measured after cycle 4 of induction KID (each cycle is 28 days)

Secondary outcomes

1

Overall Response Rate (ORR)

Assessment of overall response rate (ORR) of newly diagnosed transplant-eligible MM patients.

Time frame
Participants will be followed for response assessment every 28 days until progression of disease or a subsequent myeloma regimen has been started. On treatment study duration will last up to 12 months; Post treatment follow up will last up to two years.
2

Progression Free Survival (PFS)

Assessment of progression-free survival (PFS) of newly diagnosed transplant-eligible MM patients.

Time frame
Participants will be followed for response assessment every 28 days until progression of disease or a subsequent myeloma regimen has been started. On treatment study duration will last up to 12 months; Post treatment follow up will last up to two years.
3

Overall Survival (OS)

Assessment of overall survival (OS) of newly diagnosed transplant-eligible MM patients.

Time frame
Participants will be followed for response assessment every 28 days until progression of disease or a subsequent myeloma regimen has been started. On treatment study duration will last up to 12 months; Post treatment follow up will last up to two years.

Other outcomes

Sponsors and contacts

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