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

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ClinicalTrials.gov Identifier: NCT00609817
Recruitment Status : Terminated (Lack of funding)
First Posted : February 7, 2008
Last Update Posted : June 25, 2013
Information provided by (Responsible Party):
La Jolla Pharmaceutical Company

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: GCS-100 Drug: Bortezomib/Dexamethasone Phase 1

Detailed Description:

The primary objective of this study is to evaluate the safety and the dose-limiting toxicities of GCS-100 in subjects with relapsed or relapsed/refractory multiple myeloma, and to identify the maximum tolerated dose and/or the recommended dose for further studies.

The secondary objectives of this study are (i) to evaluate the safety of treatment with GCS-100 in combination with bortezomib (VelcadeTM) in subjects whose disease has progressed on GCS-100 alone; (ii) to evaluate the response to GCS-100 alone, in combination with bortezomib in subjects whose disease has progressed on GCS-100 alone, and during dexamethasone therapy in combination with GCS 100 plus bortezomib in subjects whose disease has progressed on GCS-100 plus bortezomib; (iii) to evaluate the utility of potential surrogate markers; (iv) to perform exploratory correlative analyses of bone marrow samples to define better the mechanisms of action and response to therapy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 1/2 Study of the Safety and Efficacy of GCS-100 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
Study Start Date : May 2008
Primary Completion Date : April 2009
Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: GCS-100 Drug: GCS-100
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
Drug: Bortezomib/Dexamethasone
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.
Other Names:
  • Velcade
  • Decadron

Primary Outcome Measures :
  1. To evaluate GCS-100 related dose-limiting toxicity and to identify the maximum tolerated dose and/or the recommended dose for further studies. [ Time Frame: Up to 12 consecutive 21-day treatment cycles ]

Secondary Outcome Measures :
  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. [ Time Frame: Up to 12 consecutive 21-day treatment cycles ]

Information from the National Library of Medicine

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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:

  • 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.

Exclusion Criteria:

  • 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:

    1. Platelet count < 50,000 cells/mm3
    2. Absolute neutrophil count < 1,000 cells/mm3
    3. Hemoglobin < 8.0 g/dL (hemoglobin may be maintained by erythropoietin or transfusion)
    4. AST and/or ALT > 2.5 X the upper limit of normal
    5. Total bilirubin > 1.5 X the upper limit of normal
    6. 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.
  • If female, subject is pregnant or breastfeeding.
  • Subject has a known hypersensitivity to bortezomib, boron, and/or mannitol.
  • Subject has a concomitant disease or condition, including laboratory abnormalities, which in the opinion of the Investigator could interfere with the conduct of the study or could put the subject at unacceptable risk.

Information from the National Library of Medicine

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): NCT00609817

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Wisconsin
Froedtert & Medical College Clinics, Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
La Jolla Pharmaceutical Company
Principal Investigator: Robert Schlossman, MD Dana-Farber Cancer Institute

Responsible Party: La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT00609817     History of Changes
Other Study ID Numbers: PR-CS009
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

Keywords provided by La Jolla Pharmaceutical Company:
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
GCS 100

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors