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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 : September 20, 2019
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE June 12, 2018
First Posted Date  ICMJE June 25, 2018
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE October 18, 2018
Estimated Primary Completion Date August 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03567616 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Official Title  ICMJE 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
Brief Summary This study is designed to evaluate the safety and preliminary efficacy of venetoclax combined with pomalidomide and dexamethasone in subjects with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least 1 prior line of therapy. The study will consist of 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion). For Part 2 the subjects will be divided into 2 cohorts, subjects positive for t(11;14) translocation and subjects negative for t(11;14) translocation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: Venetoclax
    tablet; oral
    Other Names:
    • ABT-199
    • GDC-0199
  • Drug: Pomalidomide
    capsule; oral
    Other Name: Pomalyst
  • Drug: Dexamethasone
    administered orally
Study Arms  ICMJE
  • Experimental: Dose-Escalation Phase
    Dose-Escalation Phase subjects will administer venetoclax (various doses) + pomalidomide + dexamethasone.
    Interventions:
    • Drug: Venetoclax
    • Drug: Pomalidomide
    • Drug: Dexamethasone
  • 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 .
    Interventions:
    • Drug: Venetoclax
    • Drug: Pomalidomide
    • Drug: Dexamethasone
  • 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.
    Interventions:
    • Drug: Venetoclax
    • Drug: Pomalidomide
    • Drug: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: June 21, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 22, 2021
Estimated Primary Completion Date August 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Relapsed or refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the subject's last treatment regimen.
  • Measurable disease as described in the protocol.
  • Received at least 1 prior line of therapy, as described in the protocol.
  • Must meet prior antimyeloma treatment parameters, as described in the protocol, and includes:
  • Received at least 2 consecutive cycles of lenalidomide or a lenalidomide containing regimen
  • Refractory to lenalidomide
  • Exposed to a proteasome inhibitor (PI) alone or in combination with another agent.
  • Had a response of partial response (PR) or better to prior therapy based on the investigator's determination of response as defined by International Myeloma Working Group (IMWG) criteria.
  • Has t(11;14) status as described in the protocol and meets the following criteria:
  • For Part 1: MM subjects independent of cytogenetic profile.
  • For Part 2, Arm A: subject must be t(11;14) positive.
  • For Part 2, Arm B: subject must be t(11;14) negative.
  • An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Adequate kidney, liver and hematologic laboratory values.

Exclusion Criteria:

  • Previous treatment with venetoclax or other BCL-2 inhibitors, or previous treatment with pomalidomide
  • Known sensitivity to any IMiDs
  • Allogenic or syngeneic stem cell transplant within 6 months before the first dose of study drug or active ongoing graft versus host disease
  • Autologous stem cell transplant within 12 weeks before the first dose of study drug
  • Known meningeal involvement of MM
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03567616
Other Study ID Numbers  ICMJE M16-085
2017-004232-11 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Celgene
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP