A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03567616|
Recruitment Status : Suspended (Safety)
First Posted : June 25, 2018
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Venetoclax Drug: Pomalidomide Drug: Dexamethasone||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||November 9, 2018|
|Estimated Primary Completion Date :||August 20, 2020|
|Estimated Study Completion Date :||January 22, 2021|
Experimental: Dose-Escalation Phase
Dose-Escalation Phase subjects will administer venetoclax (various doses) + pomalidomide + dexamethasone.
Other Name: Pomalyst
Experimental: Expansion Phase: Arm A t(11;14) Positive
Expansion Phase Arm A in subjects positive for t(11;14) translocation will administer venetoclax + pomalidomide + dexamethasone .
Other Name: Pomalyst
Experimental: Expansion Phase: Arm B t(11;14) Negative
Expansion Phase Arm B in subjects negative for t(11;14) translocation will administer venetoclax + pomalidomide + dexamethasone.
Other Name: Pomalyst
- Number of Participants With Adverse Events [ Time Frame: From first dose of study drug until 30 days following last dose of study drug ]An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
- Overall Response Rate (ORR) [ Time Frame: Up to approximately 12 months ]ORR is defined as defined as the proportion of subjects experiencing a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
- Progression-Free Survival (PFS) [ Time Frame: Up to approximately 18 months ]PFS is defined as the number of days from the date of first dose of any study drug to the date of disease progression or death, whichever occurs first. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.
- Duration of Response (DOR) [ Time Frame: Up to approximately 24 months ]DOR defined as the number of days from the date of that subject's first documented response (PR or better) to the date of first documented disease progression (PD) or death due to multiple myeloma, whichever occurs first.
- Time-to-progression (TTP) [ Time Frame: Up to approximately 24 months ]TPP is defined aas the number of days from the date of first dose to the date of first documented PD or death due to MM, whichever occurs first.
- Cmax of Venetoclax [ Time Frame: Up to approximately 7 months ]Cmax is defined as maximum concentration observed following venetoclax administration.
- Tmax of Venetoclax [ Time Frame: Up to approximately 7 months ]Tmax is defined as time to reach the maximum observed serum concentration (Cmax) for venetoclax.
- AUC0-24 of Venetoclax [ Time Frame: Up to approximately 7 months ]AUC0-24 is defined as the area under the plasma concentration versus time curve (AUC) from time 0 to 24 hours postdose (AUC0-24).
- Cmax of pomalidomide [ Time Frame: Up to 15 days after initial study drug ]Cmax is defined as maximum concentration observed following pomalidomide administration.
- Tmax of Pomalidomide [ Time Frame: Up to 15 days after initial study drug ]Tmax is defined as time to reach the maximum observed serum concentration (Cmax) for for pomalidomide.
- AUC0-24 of Pomalidomide [ Time Frame: Up to 15 days after initial study drug ]AUC0-24 is defined as the area under the plasma concentration versus time curve (AUC) from time 0 to 24 hours postdose (AUC0-24).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567616
|United States, Georgia|
|John B. Amos Cancer Center - C /ID# 202055|
|Columbus, Georgia, United States, 31904|
|United States, Kansas|
|University of Kansas Cancer Center /ID# 201292|
|Fairway, Kansas, United States, 66205-2528|
|United States, Massachusetts|
|Dana-Farber Cancer Institute /ID# 201297|
|Boston, Massachusetts, United States, 02215|
|United States, Missouri|
|Washington University-School of Medicine /ID# 201287|
|Saint Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Duke University Hospital /ID# 200805|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Ohio State Cancer Center /ID# 202443|
|Columbus, Ohio, United States, 43210|
|United States, Oregon|
|Oregon Health and Science University /ID# 205582|
|Portland, Oregon, United States, 97239-3098|
|United States, Wisconsin|
|Aurora Health Care, Aurora Cancer Center /ID# 201153|
|Wauwatosa, Wisconsin, United States, 53226-3436|
|Hospital Clinic de Barcelona /ID# 200957|
|Barcelona, Spain, 08028|
|Hospital Vall d'Hebron /ID# 200967|
|Barcelona, Spain, 08035-999999|
|Hospital Univ Germans Trias I /ID# 200959|
|Barcelona, Spain, 08916|
|Hospital Universitario La Paz /ID# 200969|
|Madrid, Spain, 28046|
|Hospital Clinico Univ de Salamanca /ID# 200958|
|Salamanca, Spain, 37007|
|Leicester Royal Infirmary /ID# 202238|
|Leicester, England, United Kingdom, LE1 5WW|
|Univ Hospitals Birmingham NHS Foundation trust /ID# 203188|
|Birmingham, United Kingdom, B15 2TG|
|St. James University Hospital /ID# 202243|
|Leeds, United Kingdom, LS9 7TF|
|Norfolk and Norwich Univ Hosp /ID# 202240|
|Norwich, United Kingdom, NR4 7UY|
|Royal Marsden Hospital, The Ro /ID# 202242|
|Sutton, United Kingdom, SM2 5PT|
|Study Director:||AbbVie Inc.||AbbVie|