Safety and Efficacy Study of GCS-100LE in the Treatment of Multiple Myeloma

NCT00609817 | Terminated Phase 1 DMC

• 1 other identifier: PR-CS009
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

A Phase 1, open-label, dose escalation, multi-center study in patients who have been diagnosed with multiple myeloma and who have relapsed or have refractory/relapsed disease after treatment with at least 2 prior therapies.

Conditions

Multiple Myeloma

Keywords

Relapsed Multiple Myeloma; Refractory Multiple Myeloma; GCS 100

Outcome Measures

Primary Outcomes (1)

• To evaluate GCS-100 related dose-limiting toxicity and to identify the maximum tolerated dose and/or the recommended dose for further studies.

  Up to 12 consecutive 21-day treatment cycles

Secondary Outcomes (1)

• To evaluate the safety of treatment with GCS-100 in combination with bortezomib (VelcadeTM) and dexamethasone in subjects whose disease has progressed on GCS-100 alone.

  Up to 12 consecutive 21-day treatment cycles

Study Arms (1)

GCS-100

EXPERIMENTAL

Drug: GCS-100; Drug: Bortezomib/Dexamethasone

Interventions

GCS-100 DRUG

GCS-100 160mg/m2 IV (in the vein) on Study Days 1, 4, 8 and 11 for up to 12 consecutive 21-day treatment cycles. Three patients will be assigned to each cohort until maximum tolerated dose is reached. The dose levels: 1) 160 mg/m2; 2) 210 mg/m2; 3) 280 mg/m2; 4) 370 mg/m2

GCS-100

Bortezomib/Dexamethasone DRUG

Bortezomid 1.3 mg/m2 and dexamethasone 20 mg/day plus an additional 20 mg of dexamethasone on the day following each of the GCS-100/bortezomib and dexamethasone dosing. GCS-100/bortezomib and dexamethasone dosed on Study Days 1, 4, 8 and 11 of each 21-day cycle after disease progression is noted.

Also known as: Velcade, Decadron

GCS-100

Eligibility Criteria

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

You may qualify if:

• Subject is capable of understanding the purpose and risks of the study and is able to provide written Informed Consent.
• Subject is male or female, aged at least 18 years.
• Subject was diagnosed previously with multiple myeloma based on standard criteria.
• Subject has relapsed or relapsed/refractory disease following at least 2 prior therapies and/or lines of therapy (i.e., pre-planned comprehensive treatment regimens). Previously allogeneic and autologous bone marrow transplants, and prior therapy with bortezomib, are permitted.
• Subject's Karnofsky performance status is ≥ 60%.
• Subject's life expectancy is at least 3 months.
• Female subjects of childbearing potential (i.e., women who have not been surgically sterilized or have not been post-menopausal for at least 1 year), and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception throughout the study period.
• Subject is willing and able to comply with the prescribed treatment protocol and evaluations.

You may not qualify if:

• Subject is receiving concomitant medications (with the exception of bisphosphonates, erythropoietin, and/or up to 10 mg per day of prednisone, and with the exception of up to 100 mg hydrocortisone administered as premedication prior to administration of certain medications or blood products) and/or other therapy that may be active against multiple myeloma. Concurrent radiation therapy is not permitted.
• Subject received chemotherapy or other anti-cancer therapy that may be active against multiple myeloma within the 3 weeks prior to Study Day 1, and/or subject received nitrosureas within the 6 weeks prior to Study Day 1.
• Subject has not recovered from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, and/or experimental therapy.
• Subject received an investigational therapy within the 3 weeks prior to Study Day 1.
• Subject's clinical laboratory values met any of the following criteria within the 7 days prior to Study Day 1:
• Platelet count \< 50,000 cells/mm3
• Absolute neutrophil count \< 1,000 cells/mm3
• Hemoglobin \< 8.0 g/dL (hemoglobin may be maintained by erythropoietin or transfusion)
• AST and/or ALT \> 2.5 X the upper limit of normal
• Total bilirubin \> 1.5 X the upper limit of normal
• Serum creatinine \> 2 mg/dL
• Subject has a known history of human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C infection.
• Subject has a clinically relevant active infection and/or a serious co-morbid medical condition such as recent myocardial infarction, unstable angina, difficult-to-control congestive heart failure, uncontrolled hypertension, difficult-to-control cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, and/or cirrhosis.
• Subject had major surgery within the 4 weeks prior to Study Day 1.
• Subject had another malignancy within the 3 years prior to study entry, with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, or other cancer for which the subject has been disease-free for at least the past 3 years.

Sponsors & Collaborators

• La Jolla Pharmaceutical Company: lead

Study Sites (3)

University of Florida

Gainesville, Florida, 32610, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Froedtert & Medical College Clinics, Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

GCS-100; Bortezomib; Dexamethasone; Calcium Dobesilate

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; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Robert Schlossman, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 7, 2008
• Study Start: May 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

US (3)