Multiple MyelomaPhase 1NCT00821301
Study of Fluphenazine in Relapsed or Relapsed-and-Refractory Multiple Myeloma
A Phase 1 study testing Fluphenazine HCl in people with Multiple Myeloma, run by Immune Control at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of fluphenazine in patients with advanced multiple myeloma. The study will also describe the efficacy of this drug. 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?
- Fluphenazine HCl
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2008to Oct 2010
- 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
- Histologically or cytologically confirmed diagnosis of multiple myeloma that is relapsed or relapsed-and-refractory after at least 2 or more prior lines of therapy. Patients must have achieved at least minor response (MR) to at least one prior line of therapy
- Progressive disease must have occurred either during or subsequent to the patient's last treatment for multiple myeloma prior to the current enrollment
- Measurable disease defined by serum M-protein ≥1 g/dL, or urine light chain ≥200 mg/24 hours, or abnormal serum FLC ratio with involved FLC > 10 mg/dL provided serum FLC ratio is abnormal
- Age >18 years
- Eastern Cooperative Oncology Group (performance status of ≤20
- Life expectancy ≥12 weeks
Show all 15Show fewer
- Signed written informed consent per institutional and federal regulatory requirements
- Did not receive chemotherapy (including systemic steroids), immunotherapy (interferon), Imids (thalidomide/lenalidomide), proteasome inhibitors (bortezomib), or radiotherapy for at least 21 days prior to Day 1 of Cycle 1
- Did not receive any investigational treatment for at least 28 days prior to study entry
- Absolute granulocyte count of ≥1,000/μL, platelet count ≥50,000/μL, and hemoglobin ≥8.0 g/dL, with no transfusion within the preceding 7 days
- Adequate liver function defined by a bilirubin value ≤2 times the upper limit of normal (ULN), and transaminases (AST and ALT) values ≤2.5 times ULN
- Adequate renal function defined by a creatinine clearance of ≥30 mL/min
- Adequate cardiac function defined by a left ventricular ejection fraction (LVEF) ≥40%, QTc <450 msec, and no evidence of clinically significant dysrhythmias on ECG
- Patient must have substantially recovered from clinically significant toxicities from prior therapies for multiple myeloma
- Fertile men and women must agree to use a medically effective contraception method throughout the treatment period. Premenopausal women of reproductive capacity and women less than 24 months post menopause must have a negative serum pregnancy test documented prior to study entry
Who cannot join
- Patients who never achieved at least minor response (MR) to at least one prior line of therapy
- Clinical spinal cord compression syndromes (unless patient has undergone treatment, for example, surgery or radiation therapy, and neurological findings are ≤ Grade 1 and patient is off corticosteroids for spinal cord edema or on a stable regimen of < 10 mg/day prednisone equivalent
- Clinical signs of brain involvement or leptomeningeal disease
- Plasma cell leukemia (plasma cells > 2000/cubic mm)
- Women who are pregnant or breast feeding
- Other serious illness or medical condition(s) (see protocol)
Show all 15Show fewer
- Hypersensitivity to fluphenazine or other phenothiazines
- Currently being treated with hematopoietic growth factors other than erythropoietin (EPO). Treatment with hematopoietic growth factors may be started during the study with development, or worsening, of cytopenia
- Concurrent use of anticholinergics
- Concurrent use of phenothiazine and atypical antipsychotics
- Concurrent use of anti-seizure drugs, with the exception of gabapentin for treatment of neuropathy
- Grade 2 or higher persisting prior treatment-related neuropathy
- Concurrent use of systemic steroids with the exception of chronically administered steroids equivalent to ≤ 10 mg/day prednisone if patient has been on this therapy for ≥1month
- History of seizures or extrapyramidal symptoms
- History of other malignancies within the past 3 years, other than adequately treated non-melanoma skin cancer, or in situ carcinoma of the cervix, unless the other malignancy is quiescent and medical monitor approval is obtained
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Kristine Mykulowycz, RN, 215-898-1972, kristine.mykulowycz@uphs.upenn.edu
Ed Stadtmauer, MD, 215-614-0910, edward.stadtmauer@uphs.upenn.edu
- Not yet recruiting
University of Pittsburgh Cancer Institute Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Amy O'Sullivan, 412-623-4882, osullivanal@upmc.edu
Suzanne Lentzsch, MD, 412-648-6586, lentzschs@upmc.edu
- Recruiting
Cancer Therapy and Research Center at the UT Health Sciences Center at San Antonio
San Antonio, Texas, 78229
Lyanna Smith, BSN, RN, 210-450-5816, smithl6@uthscsa.edu
Swaminathan Padmanabhan, MD, 210-450-5882, PadmanabhanS@uthscsa.edu
About this study
Official title: Phase 1b Single Arm, Open Label, Multi-Center Study of Fluphenazine HCl Monotherapy in Relapsed or Relapsed-and-Refractory Multiple Myeloma
The purpose of this study is to evaluate the safety and tolerability of fluphenazine in patients with advanced multiple myeloma. The study will also describe the efficacy of this drug.
Read the detailed description
This is a multicenter, dose-escalating, Phase 1b trial in patients with relapsed or relapsed-and-refractory multiple myeloma. Patients will be dosed on Days 1 and 8 of each 21 day cycle.
This study will be conducted in two parts. In Part 1, the MTD determining portion of the study, patients will be enrolled in cohorts of 3 patients at each dose level. At least 3 patients will complete 21 days at each dose level and will be evaluated for safety and tolerability before additional patients are treated at higher doses. Doses will be increased following a modified Fibonacci scheme.
In Part 2, twelve additional patients will be enrolled at the MTD determined in Part 1 (or the dose for the highest dose cohort completed if the MTD has not been reached) to further evaluate the safety, tolerability, and preliminary efficacy of this dose regimen.
Serum fluphenazine pharmacokinetic studies will be performed during the first cycle of the therapy in all Part 1 and Part 2 consenting patients.
- Conditions
- Multiple Myeloma
- Being tested
- Fluphenazine HCl
- Keywords
- Multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluphenazine HClDrug
Also called Prolixin
Fluphenazine HCl will be administered intravenously. To quickly reach and maintain the target bone marrow concentration for 18 hours, the study drug will be administered using 3 bolus injections (0, 6, and 12 hours). Fluphenazine will be dose-escalated according to a modified Fibonacci scheme, terminating in 40% increments. Treatments will be administered on days 1 and 8 of every 21 day cycle.
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of fluphenazine.
Measured: 21 day treatment cycle(s)
Secondary outcomes (1)
Changes in serum and urine M-protein or free light chain concentrations determined using protein electrophoresis.
Measured: 21 day treatment cycle(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionAug 2010 (estimated)
- Study completionOct 2010 (estimated)
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immune Control
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bruce A Silver, M.D., FACP, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821301
- Sponsor's protocol ID
- FM-CL2
- Status last verified
- Jan 2009
- First submitted
- 9 Jan 2009
- Last updated
- 13 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Single Arm, Open Label, Multi-Center Study of Fluphenazine HCl Monotherapy in Relapsed or Relapsed-and-Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00821301
- Acronym / sponsor ID
- FM-CL2
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Immune ControlIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 13 Jan 2009 (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 evaluate the safety and tolerability of fluphenazine in patients with advanced multiple myeloma. The study will also describe the efficacy of this drug.
Detailed description
This is a multicenter, dose-escalating, Phase 1b trial in patients with relapsed or relapsed-and-refractory multiple myeloma. Patients will be dosed on Days 1 and 8 of each 21 day cycle.
This study will be conducted in two parts. In Part 1, the MTD determining portion of the study, patients will be enrolled in cohorts of 3 patients at each dose level. At least 3 patients will complete 21 days at each dose level and will be evaluated for safety and tolerability before additional patients are treated at higher doses. Doses will be increased following a modified Fibonacci scheme.
In Part 2, twelve additional patients will be enrolled at the MTD determined in Part 1 (or the dose for the highest dose cohort completed if the MTD has not been reached) to further evaluate the safety, tolerability, and preliminary efficacy of this dose regimen.
Serum fluphenazine pharmacokinetic studies will be performed during the first cycle of the therapy in all Part 1 and Part 2 consenting patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed diagnosis of multiple myeloma that is relapsed or relapsed-and-refractory after at least 2 or more prior lines of therapy. Patients must have achieved at least minor response (MR) to at least one prior line of therapy
- Progressive disease must have occurred either during or subsequent to the patient's last treatment for multiple myeloma prior to the current enrollment
- Measurable disease defined by serum M-protein ≥1 g/dL, or urine light chain ≥200 mg/24 hours, or abnormal serum FLC ratio with involved FLC > 10 mg/dL provided serum FLC ratio is abnormal
- Age >18 years
- Eastern Cooperative Oncology Group (performance status of ≤20
Key exclusion criteria (15 listed)
- Patients who never achieved at least minor response (MR) to at least one prior line of therapy
- Clinical spinal cord compression syndromes (unless patient has undergone treatment, for example, surgery or radiation therapy, and neurological findings are ≤ Grade 1 and patient is off corticosteroids for spinal cord edema or on a stable regimen of < 10 mg/day prednisone equivalent
- Clinical signs of brain involvement or leptomeningeal disease
- Plasma cell leukemia (plasma cells > 2000/cubic mm)
- Women who are pregnant or breast feeding
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 |
|---|---|---|
| Fluphenazine HClAlso: ProlixinFluphenazine HCl will be administered intravenously. To quickly reach and maintain the target bone marrow concentration for 18 hours, the study drug will be administered using 3 bolus injections (0, 6, and 12 hours). Fluphenazine will be dose-escalated according to a modified Fibonacci scheme, terminating in 40% increments. Treatments will be administered on days 1 and 8 of every 21 day cycle. | Drug | – |
Primary outcome
Tolerability of fluphenazine.
Time frame: 21 day treatment cycle(s)
1 secondary outcome
Changes in serum and urine M-protein or free light chain concentrations determined using protein electrophoresis.
Time frame: 21 day treatment cycle(s)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2009.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Bruce A Silver, M.D., FACP study director
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 Fluphenazine HCl in people with Multiple Myeloma, run by Immune Control 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 15 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: status not confirmed, as of the sponsor's last update on 13 Jan 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Roth, Ph.D. (610-941-2972, sroth@immunecontrol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of fluphenazine. (time frame: 21 day treatment cycle(s)). 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 13 Jan 2009.