Multiple Myeloma and Plasma Cell NeoplasmPhase 1/2NCT00335647
Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma
A Phase 1/2 study testing fluphenazine hydrochloride in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Immune Control at 3 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as fluphenazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- fluphenazine hydrochloride
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2006to Apr 2008
- Phase
- Phase 1/2
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed multiple myeloma
- Advanced disease
- Must be refractory to ≥ 2 different methods of standard treatment
- Measurable disease, defined as serum paraprotein ≥ 1g/L or urine light chain ≥ 200 mg/24 hours
- No brain involvement or leptomeningeal disease
- No spinal cord compression unless the following criteria are met:
- Patient has undergone prior surgery or radiotherapy
- Neurological findings are ≤ grade 1
- Patient is off steroids for spinal cord edema or is on a stable regimen of ≤ 10 mg/day of prednisone or equivalent
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if related to skeletal lesions)
- Life expectancy ≥ 12 weeks
- Absolute granulocyte count ≥ 1,000/mm^3*
- Platelet count ≥ 50,000/mm^3*
- Hemoglobin ≥ 8.0 g/dL* (no transfusion within the past 7 days)
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2 times ULN
- Creatinine clearance ≥ 30 mL/min
- LVEF ≥ 40%
- QTc < 450 msec
- No evidence of dysrhythmias on EKG
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No congestive heart failure
- No angina pectoris
- No cardiac arrhythmia
- No uncontrolled hypertension, defined as systolic blood pressure (BP) > 180 mm Hg and/or diastolic BP > 105 mm Hg
- No myocardial infarction within the past year
- No active infection
- No HIV, hepatitis B, or hepatitis C infection
- No history of psychosis
- No history of subcortical brain damage
- No hypersensitivity to fluphenazine hydrochloride or other phenothiazines
- No history of seizures or extrapyramidal symptoms
- No other serious illness or medical condition
- No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix NOTE: *Patients with values outside of this range due to infiltration by myeloma may be allowed at the discretion of the investigator
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- At least 21 days since prior chemotherapy, immunotherapy, or radiotherapy
- At least 21 days since prior and no concurrent systemic steroids
- Patients who have been taking chronically administered steroids for ≥ 1 month at a dose ≤ 10 mg/day of prednisone or equivalent are eligible
- At least 28 days since prior investigational agents
- At least 6 weeks since prior selective serotonin reuptake inhibitors (SSRIs) (a wash-out period equivalent to 5 times the terminal elimination half-life is required for tricyclic antidepressants or norepinephrine reuptake inhibitors)
- No concurrent SSRIs, tricyclic antidepressants, or norepinephrine reuptake inhibitors
- No concurrent dialysis therapy
- No concurrent hematopoietic growth factors except epoetin alfa
- Treatment with hematopoietic growth factors may be started during study if patient develops or has progressive cytopenia
- No concurrent anticholinergics or other antipsychotics
- No concurrent antiseizure drugs except Neurontin for treatment of neuropathy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, 07601
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
About this study
Official title: A Phase I/IIa, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerance, and Preliminary Activity of Intravenous High-Dose Fluphenazine HCI in Patients With Advanced Multiple Myeloma
RATIONALE: Drugs used in chemotherapy, such as fluphenazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of fluphenazine and to see how well it works in treating patients with refractory advanced multiple myeloma.
Read the detailed description
OBJECTIVES:
- Determine the safety of high-dose fluphenazine hydrochloride in patients with refractory advanced multiple myeloma.
- Determine the pharmacological properties of this drug.
- Determine the effectiveness of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive high-dose fluphenazine hydrochloride IV 3 times on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of patients receive escalating doses of fluphenazine hydrochloride until the maximum tolerated dose is determined.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Being tested
- fluphenazine hydrochloride
- Keywords
- stage III multiple myeloma, refractory multiple myeloma, stage II multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluphenazine hydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies 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 1/2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immune Control
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335647
- Sponsor's protocol ID
- CDR0000486281
- Other IDs
- IMMUNECON-FM-CL1, UPCC-IRB-5, UPCC-09405, UPCC-803972
- Status last verified
- Apr 2008
- First submitted
- 8 Jun 2006
- Last updated
- 6 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerance, and Preliminary Activity of Intravenous High-Dose Fluphenazine HCI in Patients With Advanced Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00335647
- Acronym / sponsor ID
- CDR0000486281
- Keywords
- stage III multiple myeloma, refractory multiple myeloma, stage II multiple myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Immune ControlIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Apr 2008 (actual)
- First posted
- 12 Jun 2006 (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.
RATIONALE: Drugs used in chemotherapy, such as fluphenazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of fluphenazine and to see how well it works in treating patients with refractory advanced multiple myeloma.
Detailed description
OBJECTIVES:
- Determine the safety of high-dose fluphenazine hydrochloride in patients with refractory advanced multiple myeloma.
- Determine the pharmacological properties of this drug.
- Determine the effectiveness of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive high-dose fluphenazine hydrochloride IV 3 times on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of patients receive escalating doses of fluphenazine hydrochloride until the maximum tolerated dose is determined.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 hydrochloride | Drug | – |
Primary outcome
Safety
Efficacy
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 6 Nov 2013.
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Not yet recruitingPhase 4
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing fluphenazine hydrochloride in people with Multiple Myeloma and Plasma Cell Neoplasm, 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?
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 6 Nov 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety. The study lists 2 primary outcomes in all. 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 6 Nov 2013; AzTrials last refreshed its copy on 6 Nov 2026.