Multiple MyelomaPhase 1NCT01485835
A Phase I Study of Ganetespib +/- Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study testing Ganetespib, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Emory University at 8 sites in United States.
Trial summary
The purpose of this study is to find out what effects, good and/or bad, that ganetespib and bortezomib has on you and your cancer. The investigators will determine the side effects of different dose levels of ganetespib when given alone and the effect it has on your cancer alone. 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?
- Ganetespib, Bortezomib and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2012to Sep 2015
- 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
- Males or females, age 18 years or older.
- Diagnosis of relapsed or refractory multiple myeloma (MM) and documentation of at least 2 prior therapies which must have included bortezomib and an immunomodulatory agent; there is no maximum number of prior regimens.
- Patients with measurable disease defined as at least one of the following:
- Serum M-protein ≥ 0.5 g/dl (≥ 5 g/l)
- Urine M-protein ≥ 200 mg/24 h
- Serum free light-chain (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) and an abnormal serum free light chain ratio (< 0.26 or > 1.65)
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- Measurable plasmacytoma (prior biopsy is acceptable, should be measured within 28 days of first study drug administration).
- Subject has an Eastern Cooperative Oncology Group (ECOG) ≤ 2 OR Karnofsky ≥ 60% performance status.
- Females of childbearing potential*: Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. *(FCBP - A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months).
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).
- Voluntary written informed consent before performance of any study-related procedure not part of routine medical care with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Absolute neutrophil count (ANC) ≥ 1,000 cells/dL (1.0 x 10⁹/L) (Growth factors cannot be used within 7 days of first drug administration)
- Platelet count ≥ 75 x 10⁹/L (platelet transfusions cannot be used within 4 days of first drug administration)
- Hemoglobin ≥ 8.0 g/dl
- Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 1.5 x upper limit of normal (ULN)
- Serum creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 50 mL/min (Cockcroft-Gault calculation)
- Total bilirubin ≤ 1.5 x ULN
- Serum calcium (corrected for serum albumin) or ionized calcium ≥ lower limit of normal (LLN) (treatment of hypercalcemia is allowed and subject may enroll if hypercalcemia returns to normal with standard treatment).
Who cannot join
- Patients who have received chemotherapy, immunomodulatory drugs (e.g., lenalidomide, thalidomide or pomalidomide), immunotherapy, radiation therapy, or any investigational drug(s) within 14 days before enrollment or who have not recovered from the side effects of the therapy to at least grade 1. Localized radiation therapy to a single site within 7 days is acceptable.
- Prior therapy with a heat shock protein 90 (HSP90) inhibitor.
- Daily requirement for corticosteroids (except for inhalational corticosteroids); prednisone ≤ 10mg/day or equivalent is permitted for other medical conditions.
- Prior peripheral stem cell transplant within 12 weeks of the first dose of study treatment.
- Use of venous access devices made of materials other than silicone for the infusion of ganetespib. Patients with these devices are eligible as long as the device is not used for the infusion.
- History of severe allergic or hypersensitivity reactions to excipients (e.g., Polyethylene glycol [PEG] 300 and Polysorbate 80).
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- Baseline corrected QT interval (QTc) > 470 msec or previous history of QT prolongation while taking other medications.
- Ventricular ejection fraction (Ef) ≤ 50 % at baseline.
- History of documented congestive heart failure (CHF), New York Heart Association class II/III/IV, with a history of dyspnea, orthopnea or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics. NOTE: Use of these medications for the treatment of hypertension is allowed.
- High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade atrioventricular [AV]-block, supra-ventricular arrhythmias which are not adequately rate-controlled) that require current treatment with the following anti-arrythmic drugs: flecainide, moricizine or propafenone.
- History of active current coronary artery disease or unstable angina.
- Peripheral neuropathy ≥ grade 2.
- Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation).
- Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, severe or systemic infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
Levine Cancer Institute
Charlotte, North Carolina, 28204
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Virginia Cancer Specialists
Fairfax, Virginia, 22031
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Siteman Cancer Center at Washington University
St Louis, Missouri, 63110
About this study
The purpose of this study is to find out what effects, good and/or bad, that ganetespib and bortezomib has on you and your cancer. The investigators will determine the side effects of different dose levels of ganetespib when given alone and the effect it has on your cancer alone. The investigators will also determine the side effects of ganetespib at different dose levels when given in combination with bortezomib and the effect the combination has on your cancer. The study will measure levels of the drug in your blood and bone marrow as well.
Bortezomib is a proteasome inhibitor that is approved by the US Food and Drug Administration (FDA) that is used for the treatment of multiple myeloma. The brand name for bortezomib is Velcade®.
Ganetespib is considered "investigational" because it has not received approval from the Food and Drug Administration for general use, although it has been previously tested in humans.
- Conditions
- Multiple Myeloma
- Being tested
- Ganetespib, Bortezomib, Dexamethasone
- Keywords
- Multiple Myeloma, Bortezomib, Velcade, Ganetespib
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanetespibDrug
Also called STA-9090
Standard 3+3 design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone.
BortezomibDrug
Also called Velcade
Standard 3+3 design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone.
DexamethasoneDrug
Also called Decadron
Standard 3+3 design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Ganetespib + Bortezomib + Dexamethasone | Experimental | Ganetespib: IV; days 1, 4, 8, 11; every 3 weeks
* Cohort 1: 100 mg/m²
* Cohort 2: 100 mg/m²
* Cohort 3: 120 mg/m²
* Cohort 4: 144 mg/m²
* Cohort 5: 173 mg/m²
Bortezomib: IV or subcutaneous; days 1, 4, 8, 11; every 3 weeks
* Cohort 1: 1.0 mg/m²
* Cohort 2, 3, 4, 5: 1.3 mg/m²
Dexamethasone: Oral prior to bortezomib
* Cohort 1, 2, 3, 4, 5: 20 + 20 mg
* Day of and following bortezomib Receives: Drug: Ganetespib; Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of ganetespib in combination with bortezomib and dexamethasone.
Measured: 30 days after final cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2015
- Study completionSep 2015
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.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Multiple Myeloma Research Consortium, Synta Pharmaceuticals Corp.
- Responsible party
- Principal investigator, Sagar Lonial, Emory University
- Investigators
- Sagar Lonial, MD, Principal investigator, Emory University Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485835
- Sponsor's protocol ID
- IRB00049962
- Other IDs
- WCI2005-11/MMRC037
- Status last verified
- Oct 2015
- First submitted
- 2 Dec 2011
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Ganetespib +/- Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01485835
- Acronym / sponsor ID
- IRB00049962
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Bortezomib, Velcade, Ganetespib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Multiple Myeloma Research Consortium, Synta Pharmaceuticals Corp.
- Study start
- Jan 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Dec 2011 (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.
The purpose of this study is to find out what effects, good and/or bad, that ganetespib and bortezomib has on you and your cancer. The investigators will determine the side effects of different dose levels of ganetespib when given alone and the effect it has on your cancer alone. The investigators will also determine the side effects of ganetespib at different dose levels when given in combination with bortezomib and the effect the combination has on your cancer. The study will measure levels of the drug in your blood and bone marrow as well.
Bortezomib is a proteasome inhibitor that is approved by the US Food and Drug Administration (FDA) that is used for the treatment of multiple myeloma. The brand name for bortezomib is Velcade®.
Ganetespib is considered "investigational" because it has not received approval from the Food and Drug Administration for general use, although it has been previously tested in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ganetespib + Bortezomib + Dexamethasone | Experimental | Drug: Ganetespib, Drug: Bortezomib, Drug: DexamethasoneGanetespib: IV; days 1, 4, 8, 11; every 3 weeks * Cohort 1: 100 mg/m² * Cohort 2: 100 mg/m² * Cohort 3: 120 mg/m² * Cohort 4: 144 mg/m² * Cohort 5: 173 mg/m² Bortezomib: IV or subcutaneous; days 1, 4, 8, 11; every 3 weeks * Cohort 1: 1.0 mg/m² * Cohort 2, 3, 4, 5: 1.3 mg/m² Dexamethasone: Oral prior to bortezomib * Cohort 1, 2, 3, 4, 5: 20 + 20 mg * Day of and following bortezomib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Males or females, age 18 years or older.
- Diagnosis of relapsed or refractory multiple myeloma (MM) and documentation of at least 2 prior therapies which must have included bortezomib and an immunomodulatory agent; there is no maximum number of prior regimens.
- Patients with measurable disease defined as at least one of the following:
- Subject has an Eastern Cooperative Oncology Group (ECOG) ≤ 2 OR Karnofsky ≥ 60% performance status.
- Females of childbearing potential*: Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. *(FCBP - A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months).
Key exclusion criteria (15 listed)
- Patients who have received chemotherapy, immunomodulatory drugs (e.g., lenalidomide, thalidomide or pomalidomide), immunotherapy, radiation therapy, or any investigational drug(s) within 14 days before enrollment or who have not recovered from the side effects of the therapy to at least grade 1. Localized radiation therapy to a single site within 7 days is acceptable.
- Prior therapy with a heat shock protein 90 (HSP90) inhibitor.
- Daily requirement for corticosteroids (except for inhalational corticosteroids); prednisone ≤ 10mg/day or equivalent is permitted for other medical conditions.
- Prior peripheral stem cell transplant within 12 weeks of the first dose of study treatment.
- Use of venous access devices made of materials other than silicone for the infusion of ganetespib. Patients with these devices are eligible as long as the device is not used for the infusion.
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 |
|---|---|---|
| GanetespibAlso: STA-9090Standard 3+3 design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone. | Drug | Ganetespib + Bortezomib + Dexamethasone |
| BortezomibAlso: VelcadeStandard 3+3 design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone. | Drug | Ganetespib + Bortezomib + Dexamethasone |
| DexamethasoneAlso: DecadronStandard 3+3 design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone. | Drug | Ganetespib + Bortezomib + Dexamethasone |
Primary outcome
Maximum tolerated dose (MTD) of ganetespib in combination with bortezomib and dexamethasone.
Time frame: 30 days after final cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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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.
Sagar Lonial, MD principal investigator
Emory University Winship Cancer Institute
8 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 Ganetespib, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Emory University at 8 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 18 inclusion and 15 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: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose (MTD) of ganetespib in combination with bortezomib and dexamethasone. (time frame: 30 days after final cycle). 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 12 Oct 2015.