Clinical trials: Pomalidomide
Multiple Myeloma
Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
Phase 1 is an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.
- Trial name
- NCT02548962
- Testing
- Ibrutinib, Pomalidomide, Dexamethasone
- Where
- 16 sites in United States, Australia and 4 more
- Volunteers
- 11 people
- Sponsor
- Pharmacyclics LLC.
Myelofibrosis With Myeloid Metaplasia, Myeloid Metaplasia
A Phase II Study of Pomalidomide in Myelofibrosis With Myeloid Metaplasia
The purpose of this study is to determine the safety of and to select a treatment regimen of pomalidomide (CC-4047) either as single-agent or in combination with prednisone to study further in patients with myelofibrosis with…
- Conditions
- Myelofibrosis With Myeloid Metaplasia, Myeloid Metaplasia, Myelofibrosis
- Trial name
- NCT00463385
- Testing
- Pomalidomide, Prednisone
- Where
- 11 sites in United States, Austria and 3 more
- Volunteers
- 88 people
- Sponsor
- Celgene
Carcinoma, Small Cell
A Phase I/II Study to Determine the Maximum Tolerated Dose (MTD) and Safety of CC-4047 (Pomalidomide) Administered in Conjunction With Cisplatin and Etoposide
The purpose of this study is to determine the maximum tolerated dose and safety of CC-4047 (pomalidomide) given in combination with cisplatin and etoposide in patients with extensive disease small cell lung cancer.
- Trial name
- NCT00537511
- Testing
- Pomalidomide, Cisplatin, Etoposide
- Where
- 6 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Celgene
Soft Tissue Sarcoma
Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma
The purpose of the study is to determine the safety and efficacy of single agent CC-4047 (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to prior anticancer therapy.
- Trial name
- NCT00717522
- Testing
- Pomalidomide
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Celgene
Multiple Myeloma
Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma
The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in study CC-4047-MM-003 (NCT01311687) and…
- Trial name
- NCT01324947
- Testing
- pomalidomide
- Where
- 91 sites in Australia, Belgium and 13 more
- Volunteers
- 74 people
- Sponsor
- Celgene
Healthy
A Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.
- Trial name
- NCT01474330
- Testing
- Pomalidomide
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Celgene
Multiple Myeloma
Japanese Phase 1 Study to Evaluate Tolerated Dose, Safety, and Efficacy of Pomalidomide in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
The purpose of this study is to determine the tolerated dose of pomalidomide and also to evaluate the pharmacokinetics, safety and efficacy of pomalidomide in patients with refractory or relapsed and refractory multiple myeloma.
- Trial name
- NCT01568294
- Testing
- pomalidomide
- Where
- 8 sites in Japan
- Volunteers
- 12 people
- Sponsor
- Celgene
Multiple Myeloma
Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma
To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a likelihood of benefit from the pomalidomide treatment while the medication is not commercially available
- Trial name
- PEXIUS (NCT01632826)
- Testing
- Pomalidomide
- Where
- 42 sites in United States, Canada
- Sponsor
- Celgene
Pharmacology, Clinical, Healthy
A Phase 1 Open-Label Study to Evaluate the Effect of CYP450 and P-gp Inhibition and Induction on the Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
1. To evaluate the pharmacokinetics (PK) of pomalidomide administered with the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide alone in healthy male subjects. 2.
- Trial name
- DDI (NCT01707407)
- Testing
- Pomalidomide, Ketoconazole, Fluvoxamine
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Celgene
Clinical Pharmacology, Healthy Volunteer Study
Study to Evaluate Pharmacokinetics of Pomalidomide in Hepatically Impaired Males
This study is for research purposes only and will not treat any disease or condition you may have. The study is an open label and single dose study; open label means that you, the study doctor and study staff will know which…
- Trial name
- NCT01835561
- Testing
- Pomalidomide
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Celgene
Clinical Pharmacology, Healthy Volunteer Study
A Phase 1 QT Study in Healthy Male Subjects
This is a single-center, randomized, double-blind crossover study with four treatments, four periods and four sequences to investigate the effects of orally administered pomalidomide on QT interval.
- Trial name
- QT/QTc (NCT01986894)
- Testing
- Pomalidomide, Moxifloxacin
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Celgene
Anemia, Sickle Cell
Study to Determine the Maximum Tolerated Dose, Safety and Effectiveness of Pomalidomide for Patients With Sickle Cell Disease
The purpose of the study is to determine the maximum tolerated dose, safety and effect on induction of fetal hemoglobin of pomalidomide in patients with Sickle Cell Disease.
- Trial name
- SCD-001 (NCT01522547)
- Testing
- pomalidomide
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Celgene
Primary Myelofibrosis, MPN-associated Myelofibrosis
Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence
The objective of this study is to determine whether pomalidomide is safe and effective in reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis (global…
- Trial name
- RESUME (NCT01178281)
- Testing
- Pomalidomide 0.5 mg, Pomalidomide
- Where
- 87 sites in United States, Australia and 14 more
- Volunteers
- 267 people
- Sponsor
- Celgene
Polycythemia Vera
Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)
This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of…
- Trial name
- NCT01243944
- Testing
- ruxolitinib tablets, Best Available Therapy (BAT)
- Where
- 102 sites in United States, Argentina and 16 more
- Volunteers
- 222 people
- Sponsor
- Incyte Corporation
Multiple Myeloma
Expanded Access for CC-4047
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-4047.
- Trial name
- NCT03723096
- Testing
- CC-4047
- Where
- United States
- Sponsor
- Celgene
Healthy Volunteers
Food Effect and CYP1A2 Induction Study in Healthy Subjects
This study will evaluate the effect of food and smoking on healthy older subjects taking pomalidomide.
- Trial name
- NCT02168205
- Testing
- Pomalidomide, Caffeine, Tobacco
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Celgene
Multiple Myeloma
A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study
The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma.
- Trial name
- NIMBUS (NCT01311687)
- Testing
- pomalidomide, Dexamethasone
- Where
- 94 sites in United States, Australia and 14 more
- Volunteers
- 455 people
- Sponsor
- Celgene
Multiple Myeloma
Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with relapsed and refractory multiple myeloma.
- Trial name
- NCT02462525
- Testing
- ABBV-838, Pomalidomide, Dexamethasone
- Where
- 19 sites in United States, France and 2 more
- Volunteers
- 74 people
- Sponsor
- AbbVie
Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma
Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors
Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival.
- Conditions
- Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma, Waldenstrom's Macroglobulinemia (WM), Other B-cell NHL Subtypes, Including WM
- Trial name
- NCT02071888
- Testing
- CB-839, CB-839 and low dose dexamethasone, CB-839, pomalidomide, and low dose dexamethasone
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- Calithera Biosciences, Inc
Bioequivalence
A Pilot Bioequivalence Study of Pomalidomide
Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.
- Trial name
- NCT03424928
- Testing
- Pomalidomide 4 MG Oral Capsule, Pomalidomide 4 MG Oral Capsule-Pomalyst
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.