Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma

Relapsed or Refractory Multiple Myeloma Clinical Trial

— INTREPID-1  

Official title:

(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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939183
• Other study ID #: 20160104
• Status: Completed
• Phase: Phase 1
• Start date: January 17, 2017
• Est. completion date: October 6, 2022

Study information

• Verified date: December 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 6, 2022
• Est. primary completion date: October 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

Intervention

Drug:
• Immediate Release (IR) Formulation
Immediate Release (IR) Formulation
• Gastro-Retentive (GR) Formulation
Gastro-Retentive (GR) Formulation
• Dexamethasone
Dexamethasone
• Pomalidomide
Pomalidomide

Locations

Country	Name	City	State
Australia	Research Site	Clayton	Victoria
Australia	Research Site	Murdoch	Western Australia
Australia	Research Site	Perth	Western Australia
Belgium	Research Site	Gent
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Toronto	Ontario
Netherlands	Research Site	Rotterdam
Spain	Research Site	Pamplona	Navarra
Spain	Research Site	Salamanca	Castilla León
United States	Research Site	Atlanta	Georgia
United States	Research Site	Bethesda	Maryland
United States	Research Site	Canton	Ohio
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Cleveland	Ohio
United States	Research Site	Hackensack	New Jersey
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	New York	New York
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Antonio	Texas
United States	Research Site	Tampa	Florida
United States	Research Site	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximum tolerated dose for each formulation of oprozomib in combination with pomalidomide and dexamethasone		The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment
Primary	Incidence of treatment-related adverse events for all subjects on continued oprozomib treatment		Data collected up to 2 months from the date of last subject enrollment.
Primary	Incidence of treatment-emergent adverse events		Data collected up to 2 months from the date of last subject enrollment.
Primary	Number of patients with changes in laboratory test results		The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment
Secondary	Maximum observed concentration (Cmax)		At the highest concentration of drug in the blood.
Secondary	Time to Cmax (tmax)		time to achieve Cmax.
Secondary	Area under the concentration-time curve		time 0 to the time of last quantifiable concentration (AUClast)
Secondary	Overall response		All efficacy assessments will follow IMWG uniform response criteria and be performed every 4 weeks (± 1 week).
Secondary	Best overall response		All efficacy assessments will follow IMWG uniform response criteria and be performed every 4 weeks (± 1 week).
Secondary	Progression free survival		4 months
Secondary	Duration of response		4 months

External Links

•   AmgenTrials clinical trials website