Multiple MyelomaPhase 1NCT00609817
Safety and Efficacy Study of GCS-100LE in the Treatment of Multiple Myeloma
A Phase 1 study testing GCS-100 and Bortezomib/Dexamethasone in people with Multiple Myeloma, run by La Jolla Pharmaceutical Company at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- GCS-100 and Bortezomib/Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2008to Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
University of Florida
Gainesville, Florida, 32610
Froedtert & Medical College Clinics, Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- GCS-100, Bortezomib/Dexamethasone
- Keywords
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma, GCS 100
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCS-100Drug
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
Bortezomib/DexamethasoneDrug
Also called Velcade, Decadron
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.
| Study group | Role | What they receive |
|---|---|---|
| GCS-100 | Experimental | Not described Receives: Drug: GCS-100; Drug: Bortezomib/Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate GCS-100 related dose-limiting toxicity and to identify the maximum tolerated dose and/or the recommended dose for further studies.
Measured: 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.
Measured: Up to 12 consecutive 21-day treatment cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Jolla Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Schlossman, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609817
- Sponsor's protocol ID
- PR-CS009
- Status last verified
- Jun 2013
- First submitted
- 24 Jan 2008
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00609817
- Acronym / sponsor ID
- PR-CS009
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma, GCS 100
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 9 participants (actual)
- Lead sponsor
- La Jolla Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GCS-100 | Experimental | Drug: GCS-100, Drug: Bortezomib/Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%.
Key exclusion criteria (18 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GCS-100GCS-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 | GCS-100 |
| Bortezomib/DexamethasoneAlso: Velcade, DecadronBortezomid 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. | Drug | GCS-100 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Schlossman, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GCS-100 and Bortezomib/Dexamethasone in people with Multiple Myeloma, run by La Jolla Pharmaceutical Company at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: Up to 12 consecutive 21-day treatment cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2013.