Pomalidomide
Drugcapsule, oral
Other names: Pomalyst
NCT Number: NCT03539744
A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
Liverpool Hospital /ID# 202431, Liverpool, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
capsule, oral
Other names: Pomalyst
oral, locally available form
tablet; oral
Other names: ABT-199, GDC-0199
Time frame: Up to approximately 43 months from first randomization
PFS is defined as the time in days from subject randomization to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 43 months from first randomization
ORR is defined as the percentage of participants with documented best response (sCR, CR, VGPR or partial response [PR]) prior to first documented PD.
Time frame: Up to approximately 43 months from first randomization
VGPR or better response rate is defined as the proportion of participants with documented stringent complete response (sCR), complete response (CR), or VGPR.
Time frame: Up to approximately 51 months from first randomization
OS is defined as the number of days from the date that the participant was randomized to the date of the participant's death.
Time frame: Up to approximately 43 months from first randomization
MRD defined as the percentage of participants with MRD negativity status. MRD negativity will be defined at 10^-5 threshold as measured by centralized testing of bone marrow aspirate samples by next generation sequencing (NGS).
Time frame: Up to approximately 51 months from first randomization
Time to deterioration in disease symptoms is measured by the disease symptom domain of the European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20).
Time frame: Up to approximately 51 months from first randomization
Time to deterioration in physical functioning is measured by the physical functioning domain of European Organization for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30).
Time frame: Up to approximately 51 months from first randomization
Change from baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a score.
Time frame: Up to approximately 51 months from first randomization
Change from baseline in the Brief Pain Inventory - Short Form (BPI-SF) worst pain score.
Time frame: Up to approximately 51 months from first randomization
EQ-5D-5L consists of 2 components: the EQ-5D descriptive system and the EQ visual analog scale (VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the participant's self-rated health on a vertical VAS where the endpoints are labelled "The best health you can imagine" and "The worst health you can imagine."
Time frame: Up to approximately 51 months from first randomization
EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
Time frame: Up to approximately 51 months from first randomization
EORTC QLQ-MY20 includes scales for disease symptoms, side effects of treatment, future perspective, and body image. Values for each scale range from 0 to 100.
Time frame: Up to approximately 43 months from first randomization
DOR for a participant is defined as the number of days from the date of first documented response (PR or better) to the date of first documented PD or death due to multiple myeloma, whichever occurs first.
Time frame: Up to approximately 43 months from first randomization
TTP for a participant is defined as the number of days from the date of randomization to the date of first documented PD or death due to multiple myeloma, whichever occurs first.
Time frame: Up to approximately 43 months from first randomization
TTR for a participant is defined as the number of days from the date of randomization to the date of first documented response (PR or better).
Time frame: Up to approximately 225 days from initial dose
Maximum plasma concentration (Cmax) of venetoclax
Time frame: Up to approximately 225 days from initial dose
Observed plasma concentration at trough (Ctrough) of venetoclax.
Time frame: Up to approximately 51 months from first randomization
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
AbbVie
Industry
A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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