Study of Oprozomib and Dexamethasone, in Combination With Lenalidomide or Oral Cyclophosphamide in Patients With Newly Diagnosed Multiple Myeloma

  • Interventional
  • Recruiting
  • NCT01881789
Eligibility Details Visit Clinicaltrials.gov

Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone, in Combination With Lenalidomide or Oral Cyclophosphamide in Patients With Newly Diagnosed Multiple Myeloma

Phase 1b: - To establish the maximum tolerated dose (MTD) of oprozomib and dexamethasone administered in combination with lenalidomide or oral cyclophosphamide - To evaluate the safety and tolerability of oprozomib and dexamethasone administered in combination with lenalidomide or oral cyclophosphamide Phase 2: - To estimate the overall response rate (ORR) and complete response rate (CRR) - To evaluate the safety and tolerability of oprozomib and dexamethasone administered in combination with lenalidomide or oral cyclophosphamide Secondary Objectives: - To evaluate population pharmacokinetic (PK) parameter estimates of oprozomib and variability in these estimates when administered in combination with dexamethasone and lenalidomide or oral cyclophosphamide - To estimate the duration of response (DOR) - To estimate progression-free survival (PFS)

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Key Inclusion Criteria:

         - Newly diagnosed, symptomatic multiple myeloma patients for whom treatment is indicated per the NCCN guidelines, and for whom a hematopoietic stem cell transplant is not planned or scheduled during the study or are considered ineligible for hematopoietic stem cell transplant, with measurable disease

         - Creatinine clearance of ≥ 50 mL/min (measured or calculated using the Cockcroft and Gault formula)

        Key Exclusion Criteria:

         - Any prior systemic antimyeloma therapy except oral steroids (dexamethasone up to a total dose of 160 mg or equivalent within 14 days prior to the first dose of study treatment). Use of topical or inhaled steroids is acceptable

         - Radiation therapy within 2 weeks prior to first dose

         - Major surgery within 3 weeks prior to first dose

         - Active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose

         - Clinical significant gastrointestinal bleeding in the 6 months prior to Cycle 1 Day 1 (C1D1) first dose

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

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

At a Glance

National Government IDNCT01881789

IRB#IRB14-0042

Lead SponsorAmgen

Lead PhysicianAndrzej Jakubowiak

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting