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An Open-Label Phase 1/2 Study of the Safety and Efficacy of GCS-100 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

An Open-Label Phase 1/2 Study of the Safety and Efficacy of GCS-100 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Up to 12 consecutive 21-day treatment cycles

Safety Issue:

Yes

Principal Investigator

Robert Schlossman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

PR-CS009

NCT ID:

NCT00609817

Start Date:

May 2008

Completion Date:

April 2009

Related Keywords:

  • Multiple Myeloma
  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma
  • GCS 100
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of FloridaGainesville, Florida  32610-0277
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Froedtert & Medical College Clinics, Medical College of WisconsinMilwaukee, Wisconsin  53226