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

Amgen

Status and phase: Completed; Phase 1

Conditions: Relapsed or Refractory Multiple Myeloma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02939183

20160104

Details and patient eligibility

About

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

Full description

A multicenter, non-randomized, open-label, dose-exploration study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in participants 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Participant must have a pathologically documented, definitively diagnosed, multiple myeloma relapse, 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.
• Participant 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.
• POEM syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
• Plasma cell leukemia (> 2.0 X10^9/L circulating plasma cells by standard differential).
• Waldenstrom's macroglobulinemia.
• Other Exclusion Criteria May Apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 5 patient groups

Part 1 Oprozomib Immediate-release (IR) + Dexamethasone

Experimental group

Description:

Oprozomib IR plus dexamethasone

Treatment:

Drug: Immediate Release (IR) Formulation

Drug: Dexamethasone

Part 1 Oprozomib Gastro-retentive (GR) + Dexamethasone

Experimental group

Description:

Oprozomib GR plus dexamethasone

Treatment:

Drug: Gastro-Retentive (GR) Formulation

Drug: Dexamethasone

Part 2 Oprozomib IR + Pomalidomide + Dexamethasone

Experimental group

Description:

Oprozomib IR plus pomalidomide and dexamethasone

Treatment:

Drug: Immediate Release (IR) Formulation

Drug: Pomalidomide

Drug: Dexamethasone

Part 2 Oprozomib GR + Pomalidomide + Dexamethasone

Experimental group

Description:

Oprozomib GR plus pomalidomide and dexamethasone

Treatment:

Drug: Gastro-Retentive (GR) Formulation

Drug: Pomalidomide

Drug: Dexamethasone

Open-label Roll-over

Experimental group

Description:

Oprozomib GR monotherapy, or oprozomib GR plus dexamethasone

Treatment:

Drug: Gastro-Retentive (GR) Formulation

Drug: Dexamethasone