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Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

Inclusion Criteria


INCLUSION CRITERIA:

- Diagnosis of multiple myeloma with measureable disease

- Patients requiring therapy who have relapsed and/or are refractory to their last
therapy and have been treated with at least 1, but not more than 5 lines of multiple
myeloma therapy.

EXCLUSION CRITERIA:

- Radiation therapy within 2 weeks prior to first dose. Localized radiation therapy
within 1 week prior to first dose.

- Immunotherapy/standard myeloma therapy within 2 weeks; prior stem cell transplant
(SCT) therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the
prior 16 weeks)

- Participation in an investigational therapeutic study within 3 weeks prior to first
dose

- Patients who failed to respond to carfilzomib treatment defined as not having
achieved ≥ PR during therapy

- Carfilzomib exposure within 6 months prior to first dose

- Prior oprozomib exposure

- Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the
first dose

- Other malignancy within the past 3 years with the exception of adequately treated
basal cell carcinoma of the skin, squamous cell skin cancer, thyroid cancer,
carcinoma in situ of the cervix, carcinoma in situ of the breast, prostate cancer of
Gleason Score 6 or less with stable prostate specific antigen levels, or cancer
considered cured by surgical resection.

- Plasma cell leukemia

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the MTD (Phase 1b)

Outcome Description:

Phase 1b- Determine the Maximum Tolerated Dose (MTD) of oprozomib given orally, once daily, on 2 different schedules: 5 consecutive days every 14 days (bimonthly) or 2 consecutive days every 7 days (weekly) for a 14-day treatment cycle, both schedules given in combination with dexamethasone

Outcome Time Frame:

6 weeks to 18 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

2012-001

NCT ID:

NCT01832727

Start Date:

May 2013

Completion Date:

December 2015

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • oprozomib
  • OPZ
  • ONX 0912
  • Onyx
  • proteasome inhibitor
  • oprozomib tablets
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Center for Cancer and Blood Disorders Bethesda, Maryland  20817