Study of Combination PS-341 and Thalidomide in Multiple Myeloma
This study has been completed.
Sponsor:
University of Arkansas
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00083460
First received: May 24, 2004
Last updated: July 30, 2010
Last verified: July 2010
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Purpose
The purpose of this study is to assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma, and to find the most appropriate doses of PS-341 and thalidomide in the combination.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: PS-341 Drug: Thalidomide Drug: Dexamethasone |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | UARK 2001-37, A Phase I Exploratory Study of Combination PS-341 and Thalidomide in Refractory Multiple Myeloma |
Resource links provided by NLM:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Dexamethasone
Thalidomide
Dexamethasone acetate
Dexamethasone sodium phosphate
Bortezomib
U.S. FDA Resources
Further study details as provided by University of Arkansas:
Primary Outcome Measures:
- Assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma [ Time Frame: until pt progresses or unexceptible toxicity ] [ Designated as safety issue: Yes ]
| Enrollment: | 86 |
| Study Start Date: | December 2001 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: PS-341
Arm 1 a dose of 1.0mg/m2. Arm 2 a dose of 1.3mg/m2
Drug: Thalidomide
In cohort 1, a dose of 50mg for cycles 2-8. Cohort 2, 100mg for cycles 2-8. Cohort 3, 150mg for cycles 2-8. Cohort 4, 200mg for cycles 2-8.
Drug: Dexamethasone
A dose of 20mg for cylces 3-8.
|
| Active Comparator: 2 |
Drug: PS-341
Arm 1 a dose of 1.0mg/m2. Arm 2 a dose of 1.3mg/m2
Drug: Thalidomide
In cohort 1, a dose of 50mg for cycles 2-8. Cohort 2, 100mg for cycles 2-8. Cohort 3, 150mg for cycles 2-8. Cohort 4, 200mg for cycles 2-8.
Drug: Dexamethasone
A dose of 20mg for cylces 3-8.
|
Detailed Description:
Patients will be enrolled in groups of 6-10 patients, each receiving a low dose of PS-341 (1.0 mg/m2) and different dose levels of thalidomide (50, 100, 150, and 200 mg). The first six patients in each group will receive PS-341 alone for the first cycle, and thalidomide will be added on day 22. If the combination is found to be safe in these first 6 patients, the remaining patients in each group will be enrolled. Initially, these patients will receive PS-341 alone and thalidomide will be added subsequently, if deemed safe based on the first 6 patients in each thalidomide dose cohort.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- History of histologically documented multiple myeloma with relapsed or resistant disease, defined as previously treated with/without autologous stem cell transplantation and is either relapsing or is resistant after > 1 line of prior therapy for myeloma
- Patients can not be eligible for MTRC phase III protocols of higher priority
- Performance status of greater than or equal to 2 as per SWOG scale
- Patients must have an absolute neutrophil count > 750/mm3, and a platelet count greater than or equal to 25,000/mm3
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval
- Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Male or female adults of at least 18 years of age.
- Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations
Exclusion Criteria:
- Chemotherapy or radiotherapy received within the previous 2 weeks
- Prior Treatment of PS-341
- Significant neurotoxicity, defined as grade greater than or equal to 2 neurotoxicity per NCI Common Toxicity Criteria
- POEMS Syndrome
- Non-secretory multiple myeloma
- Active infection requiring antibiotics
- Clinically significant hepatic dysfunction in the absence of liver metastases as noted by bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis
- New York Hospital Association (NYHA) Class III or Class IV heart failure
- Myocardial infarction within the last 6 months
- Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
- Severe renal dysfunction defined as a creatinine clearance < 20 cc/min.
- Absolute neutrophil count < 750/mm3, and a platelet count < 25,000/mm3
- Pregnant or potential for pregnancy
- Breast-feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083460
Locations
| United States, Arkansas | |
| University of Arkansas for Medical Sciences/MIRT | |
| Little Rock, Arkansas, United States, 72205 | |
Sponsors and Collaborators
University of Arkansas
Investigators
| Principal Investigator: | Barlogie Barthel, M.D. Ph.D | University of Arkanas for Medical Sciences website |
More Information
Additional Information:
No publications provided
| Responsible Party: | Brooke Carter, CRA, University_Of_Arkansas |
| ClinicalTrials.gov Identifier: | NCT00083460 History of Changes |
| Other Study ID Numbers: | UARK 2001-37 |
| Study First Received: | May 24, 2004 |
| Last Updated: | July 30, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arkansas:
|
Multiple Myeloma Thalidomide Velcade |
PS-341 Refractory Bortezomid |
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 acetate |
Dexamethasone Dexamethasone 21-phosphate Bortezomib Thalidomide BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids |
ClinicalTrials.gov processed this record on May 19, 2013