--- title: Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma nct_id: NCT00335647 overall_status: COMPLETED phase: PHASE1, PHASE2 sponsor: Immune Control study_type: INTERVENTIONAL primary_condition: Multiple Myeloma and Plasma Cell Neoplasm countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00335647.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00335647" ct_last_update_post_date: 2013-11-06 last_seen_at: "2026-05-12T07:30:26.514Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma **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 **NCT ID:** [NCT00335647](https://clinicaltrials.gov/study/NCT00335647) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE1, PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 30 - **Lead Sponsor:** Immune Control - **Conditions:** Multiple Myeloma and Plasma Cell Neoplasm - **Start Date:** 2006-01 - **CT.gov Last Update:** 2013-11-06 ## Brief 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. 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Interventions - **fluphenazine hydrochloride** (DRUG) ## Primary Outcomes - **Safety** - **Efficacy** ## Locations (3) - Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, United States - Long Island Jewish Medical Center, New Hyde Park, New York, United States - Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.hackensack university medical center cancer center|hackensack|new jersey|united states` — added _(2026-05-12)_ - `locations.long island jewish medical center|new hyde park|new york|united states` — added _(2026-05-12)_ - `locations.abramson cancer center of the university of pennsylvania|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00335647.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00335647* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*