Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellCentric Ltd.
About this trial
The purpose of this study is to learn more about the anti-cancer activity of inobrodib, when given in combination with pomalidomide and dexamethasone, in patients with multiple myeloma that has come back following treatment and which no longer responds to available therapies. The study treatment will not be compared to any other treatment and patients will know what treatment they are receiving. This study will also further explore the side effects of inobrodib in combination with these other medicines.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female ≥18 years of age
Prior diagnosis of MM as defined according to IMWG criteria and relapsed or refractory to the last line of therapy
Eastern Co-operative Oncology Group (ECOG) performance status of 0 to 2
Adequate hematological, renal and hepatic function
Disqualifiers
Use of any investigational agent, chemotherapy, immunotherapy or anticancer agent from a previous clinical study within 14 days or 5 half-lives of first dose of study treatment, whichever is shortest
Prior treatment with p300/CBP bromodomain inhibitors
Known or suspected severe allergies to any active or inactive ingredients in the study medications (inobrodib, pomalidomide, dexamethasone) or any prior immunomodulatory drug (lenalidomide, thalidomide)
Treatment with medicines or herbal supplements or foods (e.g. strong CYP3A4 inducers or inhibitors) that would interfere with treatment
Trial design
Design model
Single group
Treatments tested in this trial
Inobrodib
Drug20 mg orally twice daily (b.i.d.) 4 days on / 3 days off for each 28-day cycle.
Pomalidomide
Drug4 mg orally once daily on Day 1 to 21 of each 28-day cycle
Dexamethasone
Drug40 mg orally once daily on Days 1, 8, 15 and 22 for each 28-day cycle
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Inobrodib in combination with pomalidomide and dexamethasoneExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate, defined as the percentage of patients with a confirmed partial response (PR) or better, based on IMWG criteria and assessed by Independent Review Committee (IRC)
Time frame
Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)Secondary outcomes
1
ORR, defined as the percentage of patients with a confirmed PR or better, based on IMWG criteria assessed by Investigator
Time frame
Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)2
Duration of Response (DoR), defined as the duration of overall response by investigator and IRC
Time frame
Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)3
Time to Response (TTR), defined as time to confirmed PR or better, by investigator and IRC
Time frame
Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)4
Very Good Partial Response (VGPR) or better rate, defined as the percentage of patients with a confirmed VGPR or better, based on IMWG criteria and assessed by investigator and IRC
Time frame
Assessed from enrollment to date of progressive disease or death from any cause, until the end of study (up to 48 months)Sponsors and contacts
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Source ClinicalTrials.gov