Study of Oprozomib and Dexamethasone, in Combination With Lenalidomide or Oral Cyclophosphamide in Patients With Newly Diagnosed Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT01881789 |
Recruitment Status :
Completed
First Posted : June 20, 2013
Last Update Posted : October 17, 2019
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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)
Condition or disease | Intervention/treatment | Phase |
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Multiple Myeloma | Drug: Oprozomib Drug: Lenalidomide Drug: Dexamethasone Drug: Cyclophosphamide | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | August 2013 |
Actual Primary Completion Date : | September 23, 2019 |
Actual Study Completion Date : | September 23, 2019 |

Arm | Intervention/treatment |
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Experimental: Oprozomib, Lenalidomide and Dexamethasone (ORd)
Subjects will receive oprozomib administered orally, once daily on Days 1, 2, 8, 9, 15,16, 22 and 23 in combination with lenalidomide at a dose of 25 mg on Days 1-21, and dexamethasone at a dose of 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23 of 28-day cycles.
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Drug: Oprozomib
Subjects will receive Oprozomib extended release (ER) Tablets (hereafter referred to as oprozomib) administered orally, once daily on 1, 2, 8, 9, 15,16, 22 and 23 of 28-day cycles
Other Name: Oprozomib ER tablets Drug: Lenalidomide Subjects will receive lenalidomide 25 mg on Days 1-21 of 28 day cycles
Other Name: Revlimid Drug: Dexamethasone Subjects will receive dexamethasone 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23 of 28 day cycles |
Experimental: Oprozomib, Cyclophosphamide and Dexamethasone (OCyd)
Subjects will receive oprozomib administered orally, once daily on Days 1, 2, 8, 9, 15, 16, 22 and 23 in combination with oral cyclophosphamide at a dose of 300 mg/m2 on Days 1, 8, and 15, and dexamethasone at a dose of 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23 of 28-day cycles
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Drug: Oprozomib
Subjects will receive Oprozomib extended release (ER) Tablets (hereafter referred to as oprozomib) administered orally, once daily on 1, 2, 8, 9, 15,16, 22 and 23 of 28-day cycles
Other Name: Oprozomib ER tablets Drug: Dexamethasone Subjects will receive dexamethasone 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23 of 28 day cycles Drug: Cyclophosphamide Subjects will receive cyclophophamide 300 mg/m2 on Days 1, 8 and 15 of 28 day cycles
Other Name: Cytoxan |
- Maximum Tolerated Dose (MTD) [ Time Frame: 6 months ]For each dosing schedule, the MTD will be defined as the highest dose at which a DLT is observed in fewer than 2 of 6 patients. DLT is defined as any of the following treatment-related events occurring in the first 28 days of treatment.
- Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 36 months ]Safety and tolerability of oprozomib and dexamethasone administered in combination with lenalidomide or oral cyclophosphamide, as defined by the type, incidence, severity, and outcome of Adverse Events (AEs).
- Overall Response Rate (ORR) [ Time Frame: 14 months ]The antitumor activity of oprozomib and dexamethasone administered in combination with lenalidomide or oral cyclophosphamide, as measured by overall response rate (ORR).
- Complete Response Rate (CRR) [ Time Frame: 17 months ]The antitumor activity of oprozomib and dexamethasone administered in combination with lenalidomide or oral cyclophosphamide, as measured by complete response rate (CRR).
- Population Pharmacokinetic (PK) Parameters - Apparent Clearance [ Time Frame: 18 months ]The Apparent Clearance is defined as the amount of drug administered (dose) divided by the plasma concentration-time curve (AUC) of oprozomib and its metabolites at various time points.
- Population Pharmacokinetic (PK) Parameters - Volume of Distribution [ Time Frame: 18 months ]The Volume of Distribution is defined as the amount of oprozomib administered (dose) divided by initial oprozomib plasma concentration.
- Duration of Response (DOR) [ Time Frame: 42 months ]Duration of Response is defined as the time from first evidence of partial response (PR) or better to confirmation of disease progression or death due to any cause.
- Progression-Free Survival (PFS) [ Time Frame: 42 months ]Progression-Free Survival is defined as the time from the start of treatment to disease progression or death (due to any cause), whichever comes first.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881789
United States, Alabama | |
Clearview Cancer Institute | |
Huntsville, Alabama, United States | |
United States, California | |
Providence St. Joseph's Hospital | |
Burbank, California, United States | |
David Geffen School of Medicine at UCLA | |
Los Angeles, California, United States | |
Monterey Bay Oncology Corp DBA Pacific Cancer Care | |
Salinas, California, United States | |
United States, Colorado | |
Colorado Blood Cancer Institute | |
Denver, Colorado, United States | |
United States, Florida | |
H. Lee Moffit Cancer Center & Research Institute | |
Tampa, Florida, United States | |
United States, Illinois | |
University of Chicago Medical Center | |
Chicago, Illinois, United States | |
United States, Indiana | |
Indiana University Health Melvin and Bren Simon Cancer Center | |
Indianapolis, Indiana, United States | |
United States, Maryland | |
Center for Cancer & Blood Disorders | |
Bethesda, Maryland, United States | |
United States, North Carolina | |
The University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States | |
United States, Texas | |
University of Texas M.D. Anderson Cancer Center | |
Houston, Texas, United States | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States | |
United States, Wisconsin | |
Froedtert Hospital and the Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States |
Study Director: | MD | Amgen |
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT01881789 History of Changes |
Other Study ID Numbers: |
OPZ003 |
First Posted: | June 20, 2013 Key Record Dates |
Last Update Posted: | October 17, 2019 |
Last Verified: | October 2019 |
multiple myeloma proteasome inhibitor oprozomib orpozomib tablets |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone |
Dexamethasone acetate Cyclophosphamide Lenalidomide BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |