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Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma (INTREPID-1)

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: NCT02939183
Recruitment Status : Active, not recruiting
First Posted : October 19, 2016
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE October 18, 2016
First Posted Date  ICMJE October 19, 2016
Last Update Posted Date December 24, 2019
Actual Study Start Date  ICMJE January 17, 2017
Estimated Primary Completion Date December 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
  • Determine the maximum tolerated dose for each formulation of oprozomib in combination with pomalidomide and dexamethasone [ Time Frame: The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment ]
  • Incidence of treatment-related adverse events for all subjects on continued oprozomib treatment [ Time Frame: Data collected up to 2 months from the date of last subject enrollment. ]
  • Incidence of treatment-emergent adverse events [ Time Frame: Data collected up to 2 months from the date of last subject enrollment. ]
  • Number of patients with changes in laboratory test results [ Time Frame: The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
Determine the maximum tolerated dose for each formulation of oprozomib in combination with pomalidomide and dexamethasone [ Time Frame: The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
  • Maximum observed concentration (Cmax) [ Time Frame: At the highest concentration of drug in the blood. ]
  • Time to Cmax (tmax) [ Time Frame: time to achieve Cmax. ]
  • Area under the concentration-time curve [ Time Frame: time 0 to the time of last quantifiable concentration (AUClast) ]
  • Overall response [ Time Frame: All efficacy assessments will follow IMWG uniform response criteria and be performed every 4 weeks (± 1 week). ]
  • Best overall response [ Time Frame: All efficacy assessments will follow IMWG uniform response criteria and be performed every 4 weeks (± 1 week). ]
  • Progression free survival [ Time Frame: 4 months ]
  • Duration of response [ Time Frame: 4 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma
Official Title  ICMJE (INTREPID-1) A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Brief Summary A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.
Detailed Description A multicenter, non-randomized, open-label, dose-exploration study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma. The study will be conducted in two parts. Part 1 will evaluate the formulations of oprozomib in combination with dexamethasone only. Part 2 will evaluate the formulations of oprozomib administered at increasing dose levels (dose escalation) in combination with pomalidomide and dexamethasone.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed or Refractory Multiple Myeloma
Intervention  ICMJE
  • Drug: Immediate Release (IR) Formulation
    Immediate Release (IR) Formulation
  • Drug: Gastro-Retentive (GR) Formulation
    Gastro-Retentive (GR) Formulation
  • Drug: Dexamethasone
    Dexamethasone
  • Drug: Pomalidomide
    Pomalidomide
Study Arms  ICMJE
  • Experimental: Part 1 Arm 1
    Oprozomib (Immediate Release) plus dexamethasone
    Interventions:
    • Drug: Immediate Release (IR) Formulation
    • Drug: Dexamethasone
  • Experimental: Part 1 Arm 2
    Oprozomib (Gastro-retentive) plus dexamethasone
    Interventions:
    • Drug: Gastro-Retentive (GR) Formulation
    • Drug: Dexamethasone
  • Experimental: Part 2 Arm 1
    Oprozomib (Immediate release) plus pomalidomide and dexamethasone
    Interventions:
    • Drug: Immediate Release (IR) Formulation
    • Drug: Dexamethasone
    • Drug: Pomalidomide
  • Experimental: Part 2 Arm 2
    Oprozomib (Gastro-retentive) plus pomalidomide and dexamethasone
    Interventions:
    • Drug: Gastro-Retentive (GR) Formulation
    • Drug: Dexamethasone
    • Drug: Pomalidomide
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 21, 2019)
61
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2016)
38
Estimated Study Completion Date  ICMJE December 23, 2020
Estimated Primary Completion Date December 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  • Subject must have a pathologically documented, definitively diagnosed, multiple myeloma relapsed, or refractory progressive disease after at least 2 lines of therapy for multiple myeloma. Prior therapeutic treatment or regimens must include a proteasome inhibitor and lenalidomide.
  • Subject must be willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines).
  • Measurable disease (assessed within 28 days prior to day 1)
  • Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
  • Other Inclusion Criteria May Apply

Exclusion Criteria

  • Currently receiving treatment in another investigational device or drug study, or less than 28 days or 5 half-lives whichever is shorter since ending treatment on another investigational device or drug study(s).
  • Previously received an allogeneic stem cell transplant and the occurrence of one or more of the following: received the transplant within 6 months prior to study day 1;received immunosuppressive therapy within the last 3 months prior to study day 1;having signs or symptoms of acute or chronic graft-versus-host disease.
  • Autologous stem cell transplant < 90 days prior to study day 1.
  • Multiple myeloma with IgM subtype.
  • POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  • Plasma cell leukemia (> 2.0 X109/L circulating plasma cells by standard differential).
  • Waldenstrom's macroglobulinemia.
  • Other Exclusion Criteria May Apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (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 Australia,   Belgium,   Canada,   Netherlands,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02939183
Other Study ID Numbers  ICMJE 20160104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: https://www.amgen.com/datasharing
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date December 2019

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