Phase 1
Completed N=27
An Open-Label, Phase 1b Study of Acalabrutinib With and Without Dexamethasone in Subjects With Multiple Myeloma
Multiple Myeloma (MM)
Source: ClinicalTrials.gov NCT02211014 ↗
Enrolled (actual)
27
Serious AEs
51.8%
Results posted
May 2020
Primary outcomePrimary: Safety Profile of Acalabrutinib With and Without Dexamethasone — 13; 14; 7; 7 Participants
Summary
To characterize the safety profile of acalabrutinib with and without dexamethasone in subjects with relapsed or refractory Multiple Myeloma (MM)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Profile of Acalabrutinib With and Without Dexamethasone |
13; 14; 7; 7; 5; 9 | — |
| SECONDARY Pharmacokinetic (PK) Parameters Calculated for Acalabrutinib: AUC0-4, AUClast, AUCINF, Cmax, Tmax, λz, t1/2, CL/F, and Vz/F. PK Parameters Calculated for Dexamethasone: Tmax, Cmax, AUC0-4 and AUClast. |
524; 437; 271; 607; 604; 621 | — |
| SECONDARY Bruton Tyrosine Kinase (BTK) Occupancy |
0; 0; 98.5; 98.5; 93.2; 94.3 | — |
| SECONDARY Response Assessed According to Guidelines Proposed by the International Myeloma Workshop Consensus Panel and European Group for Blood and Marrow Transplant |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women ≥ 18 years of age.
- A confirmed diagnosis of MM, which has relapsed after, or been refractory to ≥ 1 prior therapy for MM, and is progressing at the time of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
Exclusion Criteria
- A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, gastric bypass, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- Breast feeding or pregnant
Data sourced from ClinicalTrials.gov (NCT02211014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.