Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01881789 · ClinicalTrials.gov registry record · Phase 1
Oprozomib and Dexamethasone,in Combination With Lenalidomide or Oral Cyclophosphamide to Treat Newly Diagnosed Multiple Myeloma
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01881789: Clinical Trial Phase 1 study, sponsored by Amgen.
NCT01881789 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01881789, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The primary objectives of this study included the following: Phase 1b: * To establish the maximum tolerated dose (MTD) of oprozomib given in combination with lenalidomide and dexamethasone (ORd) or with cyclophosphamide and dexamethasone (OCyd) * To evaluate the safety and tolerability of oprozomib and dexamethasone administered in combination with lenalidomide or oral cyclophosphamide Phase 2: * To estimate the antitumor activity of each combination regimen, as measured by overall response rate (ORR) and complete response rate (CRR) * To evaluate the safety and tolerability of each combination regimens, as assessed by the type, incidence, severity and seriousness of adverse events, and abnormalities in selected laboratory analytes
Primary Outcome
DLTs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. A DLT is defined as any of the following treatment-related events: * Any ≥ Grade 3 nonhematologic toxicity with the following conditions: * ≥ Grade 3 nausea, vomiting, diarrhea, or constipation only if for \> 7 days despite optimal supportive care * Asymptomatic Grade 3 hypophosphatemia, Grade 3 hyperglycemia or toxicity solely due to dexamethasone, ≥ Grade
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Oprozomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2013-10-28 |
| Est. Completion | 2019-09-23 |
| Phase | Phase 1 |
Why NCT01881789 stopped before completion
NCT01881789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT01881789 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01881789 about?
NCT01881789 is a clinical study titled "Oprozomib and Dexamethasone,in Combination With Lenalidomide or Oral Cyclophosphamide to Treat Newly Diagnosed Multiple Myeloma". The primary objectives of this study included the following: Phase 1b: * To establish the maximum tolerated dose (MTD) of oprozomib given in combination with lenalidomide and dexamethasone (ORd) or with cyclophosphamide and dexamethasone (OCyd) * To evaluate the safety and tolerability of oprozomi...
What is the current status of trial NCT01881789?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2013-10-28. Estimated completion is 2019-09-23.
What interventions are being tested in trial NCT01881789?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG), Oprozomib (DRUG).
Who is sponsoring clinical trial NCT01881789?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01881789's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02508038 · 22 participants · Phase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
- NCT03099356 · 22 participants · Phase 2
Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
- NCT03676647 · 22 participants
Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules
- NCT04569591 · 22 participants · NA
DDAVP for Pituitary Adenoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI