A Phase 1 interventional study of ACY-1215 and lenalidomide in Multiple Myeloma, sponsored by Celgene. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-23.
Sponsored by Celgene · Phase 1, Interventional, and Treatment
The purpose of this study is to determine the best dose of ACY-1215 in combination with lenalidomide and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. Once determined, the purpose of this study will be to determine the efficacy of ACY-1215 in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma who have had 1-3 prior therapies and who are not lenalidomide-refractory.
This is phase 1, single-arm, multicenter, open-label study in patients with relapsed or relapsed/refractory MM. The study employs a sequential group dose-escalation design to determine the DLT and MTD of ACY-1215 in combination with lenalidomide and dexamethasone, all administered orally (PO). The safety, tolerability, single- and multiple-dose PK, pharmacodynamics, and anti-tumor activity of ACY 1215 in combination with lenalidomide and dexamethasone also will be evaluated.
Each cohort will enroll 3 patients. Study drug doses will be escalated sequentially after the Safety Review Committee (SRC) reviews safety data collected in C1 (28 days) from patients enrolled at the current dose level as well as emerging data from ongoing studies of ACY-1215. If there are no DLTs (as defined in Section 5.2.6) during C1 or concerns based on data from other ongoing studies, the study will proceed with dose escalation to the next cohort following safety data review by the SRC. If 1 of 3 patients has a DLT, then up to 3 additional patients will be enrolled in that cohort; if none of the additional 3 patients experience a DLT during C1, escalation may then continue to the next cohort following SRC review. If 2 or more patients have DLTs during C1, the DLT dose level will have been reached.
The MTD is defined as the dose level immediately below the DLT dose level. A total of up to 6 additional patients may be enrolled at the MTD or other appropriate dose level to obtain additional AE, PK, pharmacodynamic, and anti-tumor activity data on ACY 1215 in combination with lenalidomide and dexamethasone.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 38 is close to the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Received any of the following antitumor therapies
Open label dosing cohorts will evaluate oral ACY-1215 (doses ranging from 40 - 480 mg days 1-5, 8-12, 15-19) in combination with oral Lenalidomide (doses ranging from 15 - 25 mg days 1-21) and oral Dexamethasone (40 mg once weekly).
Drug: ACY-1215 · Drug: lenalidomide · Drug: Dexamethasone
Dose escalation up to 480 mg administered orally on Days 1-5, 8-12 and 15-19 of a 28 day dosing schedule.
Also known as: Histone deacetylase inhibitor
Dosed on Days 1-21 of a 28 day cycle.
Also known as: Revlimid
Dosed on Days 1, 8, 15 and 22 of a 28 day treatment cycle.
Also known as: steroid
To determine DLT of ACY-1215 administered in combination with lenalidomide and dexamethasone in patient with relapsed/refractory MM
Number of participants with Dose Limiting Toxicity (DLT)
Time frame: up to 7 years
To determine MTD of ACY-1215 administered in combination with lenalidomide and dexamethasone in patient with relapsed/refractory MM
Maximum Tolerated Dose is defined as the dose level immediately below the DLT dose level.
Time frame: up to 7 years
Objective Response Rate of ACY-1215
The objective response rate is the proportion of subjects achieving an investigator conformed partial response (PR) or better, to treatment according to IMWG (International Myeloma Working Group).
Time frame: up to 7 years
Duration of Response
The duration of response is defined as the time (in weeks) from the date of the first documentation of objective response to the first documentation of objective tumor progression or death on study due to any cause, whichever comes first.
Time frame: Up to approximately 7 years
Adverse Events (AEs)
Number of participants with adverse event
Time frame: From enrollment until at least 28 days after completion of study treatment
Disease Control Rate
Disease control rate is defined as the proportion of subjects with a response (Unconfirmed or Confirmed) of SD or better, more specifically sCR, CR, VGPR, PR, MR, or SD respectively.
Time frame: Up to approximately 7 years
Progression-free Survival
PFS is defined as the time (in weeks) from the date of first dose to the date of first documentation of disease progression or death on study due to any cause, whichever comes first.
Time frame: Up to approximately 7 years
Evaluate the pharmacodynamics of ACY-1215 in combination with lenalidomide and dexamethasone in patients with relapsed or relapsed/refractory MM
Exposure-response of ACY-1215 in combination with lenalidomide and dexamethasone, including biomarkers relating to intracellular protein acetylation, levels of proteins, messenger ribonucleic acid (mRNA) and microRNA expression profiles will be analyzed for potential relationships.
Time frame: up to 28 days
Pharmacokinetic- Cmax
Maximum serum concentration
Time frame: up to 28 days
Pharmacokinetic- Cmin
Minimum observed concentration
Time frame: up to 28 days
Pharmacokinetic- Tmax
Time to maximum serum concentration
Time frame: up to 28 days
Pharmacokinetic- AUC
Area under the plasma concentration time curve
Time frame: up to 28 days
Pharmacokinetic- t1/2
Serum half-life
Time frame: up to 28 days
Plan to share: Yes — Clinical Study Report
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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