Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT00131261 |
Recruitment Status
:
Completed
First Posted
: August 18, 2005
Last Update Posted
: July 8, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Drug: PXD101 Drug: Dexamethasone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | January 2007 |
Actual Study Completion Date : | June 2007 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria
- Signed informed consent
-
A confirmed diagnosis of multiple myeloma, diagnostic criteria as follows, in patients who have failed at least two prior lines of therapy.
Diagnostic criteria for multiple myeloma:
A Monoclonal immunoglobulin (M-component) in serum of IgG-type > 30 g/l, of IgA type > 20 g/l, of IgD type or IgE type of any concentration and/or excretion of M-component in the urine of type k or l type > 1 g/24 hours.
B M-component in serum and/or urine in lower concentration than indicated above in 'A'.
C 10% or more plasma cells in bone marrow aspirate or plasmocytosis in biopsy from bone marrow or soft tissue tumor D Osteolytical bone lesions.
The diagnosis of multiple myeloma demands one of the following combinations: A+C, A+D, or B+C+D.
- Evaluable disease (as defined above)
-
Adequate bone marrow and hepatic functions including the following:
- WBC > 2.5 x 109/l, absolute neutrophil count ≥ 1.5 x 109/l, platelets ≥ 50x109/l
- Total bilirubin ≤1.5 x upper normal limit.
- AST (SGOT), ALT (SGPT) ≤2.5 x upper normal limit
- Serum potassium within normal range.
- Age ≥18 years
- Performance status (PS) ≤2 (ECOG scale)
- Estimated life expectancy greater than 3 months
- Female patients with reproductive potential with a negative serum pregnancy test within the last 7 days before trial enrollment and use a safe contraceptive during and in a period of 60 days after the trial. Fertile female partners to male participants must likewise use contraceptive.
Exclusion criteria
- Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 4 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin or nitrosourea). Exception: bisphosphonates for bone disease caused by multiple myeloma.
- Active infection or any medical condition likely to interfere with trial procedures.
- Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
- A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >500; Long QT Syndrome; the required use of concomitant medication on PXD101 infusion days that may cause Torsade de Pointes. (See Appendix B for list).
- Patients with renal insufficiency defined as a calculated creatinine clearance of < 45 ml/min.
- Clinically significant central nervous system disorders requiring neuroleptics or anti-convulsant medication.
- Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- Other malignant diseases requiring treatment
- Non-secretory multiple myeloma or symptomatic amyloidosis
- Pregnant or breast-feeding women
- Women of childbearing age and potential, who do not use effective contraception
- Known HIV positivity

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): NCT00131261
United States, California | |
James Berenson, MD, Inc | |
West Hollywood, California, United States, 90069 | |
United States, Florida | |
H. Lee Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, New York | |
Research Facility | |
New York, New York, United States, 10021 | |
Denmark | |
Rigshospitalet | |
Copenhagen, Denmark, 2100 | |
Norway | |
Research Facility | |
Bergen, Norway, N-5021 | |
Research Facility | |
Oslo, Norway, N-0407 | |
Research Facility | |
Trondheim, Norway, N-7006 | |
United Kingdom | |
Christie Hospital NHS Trust | |
Manchester, United Kingdom, M20 4BX | |
The Royal Marsden NHS Trust | |
Surrey, United Kingdom, SM2 5NG |
Study Chair: | enquiries@topotarget.com | Onxeo |
Responsible Party: | Onxeo |
ClinicalTrials.gov Identifier: | NCT00131261 History of Changes |
Other Study ID Numbers: |
PXD101-301-G |
First Posted: | August 18, 2005 Key Record Dates |
Last Update Posted: | July 8, 2015 |
Last Verified: | July 2015 |
Keywords provided by Onxeo:
Multiple Myeloma Neoplasms |
Additional relevant MeSH terms:
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 |
Belinostat 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 Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |