Study of Combination PS-341 and Thalidomide in Multiple Myeloma

NCT00083460 | Completed Phase 1 DMC

• 1 other identifier: UARK 2001-37
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Thalidomide; Velcade; PS-341; Refractory; Bortezomid

Outcome Measures

Primary Outcomes (1)

• Assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma

  until pt progresses or unexceptible toxicity

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: PS-341; Drug: Thalidomide; Drug: Dexamethasone

2

ACTIVE COMPARATOR

Drug: PS-341; Drug: Thalidomide; Drug: Dexamethasone

Interventions

PS-341 DRUG

Arm 1 a dose of 1.0mg/m2. Arm 2 a dose of 1.3mg/m2

1; 2

Thalidomide DRUG

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.

1; 2

Dexamethasone DRUG

A dose of 20mg for cylces 3-8.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences/MIRT

Little Rock, Arkansas, 72205, United States

Location

Related Links

• Myeloma Institute for Research \& Therapy website

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Thalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Barlogie Barthel, M.D. Ph.D

  University of Arkanas for Medical Sciences website

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2004
• First Posted: May 26, 2004
• Study Start: December 1, 2001
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: August 2, 2010

Record last verified: 2010-07

Locations

US (1)