Doxorubicin Hydrochloride Liposome, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

NCT00742404 | Unknown Phase 2

• 3 other identifiers: CDR0000612434ONCOTHER-X05272-DOXILMMY2010DVD study
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 12

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving bortezomib together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome together with bortezomib and dexamethasone works in treating patients with newly diagnosed multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Response rate (complete response, very good partial response, partial response, and minimal response) as assessed by modified Bladé criteria at baseline, on day 1 of each course, and at end-of-study

Secondary Outcomes (8)

• Safety and tolerability as assessed by NCI CTCAE v3.0

• Time to progression

• Time to response

• Duration of response

• Progression-free survival

Interventions

bortezomib DRUG

dexamethasone DRUG

pegylated liposomal doxorubicin hydrochloride DRUG

protein analysis GENETIC

immunologic technique OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma based on the following criteria: * Major criteria * Plasmacytomas on tissue biopsy (1) * Bone marrow plasmacytosis (\> 30% plasma cells) (2) * Monoclonal immunoglobulin spike on serum electrophoresis IgG \> 3.5 g/dL or IgA \> 2.0 g/dL and kappa or lambda light chain excretion \> 1 g/day on 24-hour urine protein electrophoresis (3) * Minor criteria * Bone marrow plasmacytosis (10% to 30% plasma cells) (a) * Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria (b) * Lytic bone lesions (c) * Normal IgM \< 50 mg/dL, IgA \< 100 mg/dL, or IgG \< 600 mg/dL (d) * Meets 1 of the following sets of diagnostic criteria: * Any two of the major criteria * Major criteria 1 and minor criteria b, c, and d * Major criteria 3 and minor criteria a or c * Minor criteria a, b, c, OR a, b, d * Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike ≥ 200 mg/24 hours, or evidence of lytic bone disease * No nonmeasurable disease (i.e., non-secretory or oligosecretory multiple myeloma) * Symptomatic, newly diagnosed, and previously untreated multiple myeloma * No POEMS syndrome (i.e., plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M-protein\], and skin changes) * No plasma cell leukemia PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Life expectancy \> 3 months * ANC ≥ 1,500/mm\^³ (≥ 1,000/mm\^³ if bone marrow is extensively infiltrated) * Platelet count ≥ 75,000/mm\^³ (≥ 50,000/mm\^³ if bone marrow is extensively infiltrated) * Hemoglobin ≥ 8.0 g/dL * AST and ALT ≤ 3.0 times upper limit of normal (ULN) * Serum bilirubin ≤ 2.0 times ULN * Creatinine clearance ≥ 30 mL/min OR creatinine \> 10 mL/min and \< 30 mL/min for patients with significant myelomatous involvement of the kidneys * Serum potassium ≥ lower limit of normal (LLN) * Serum sodium ≥ LLN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No peripheral neuropathy ≥ grade 2 within past 14 days * No impaired cardiac function or clinically significant cardiac disease, including any one of the following: * Myocardial infarction within the past 6 months * New York Heart Association class II-IV heart failure * Uncontrolled angina * Clinically significant pericardial disease * Severe uncontrolled ventricular arrhythmias * LVEF below normal by ECHO or MUGA scan * ECG evidence of acute ischemia or active conduction system abnormalities * Screening ECG abnormality must be documented by the investigator as not medically relevant * No severe hypercalcemia (i.e., serum calcium ≥ 14 mg/dL \[3.5 mmol/L\]) * No poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could preclude study treatment * No known HIV positivity or hepatitis B or C positivity * Baseline testing for HIV and hepatitis B or C is not required * No history of allergic reaction attributable to compounds of similar chemical or biological composition to doxorubicin, bortezomib, boron, or mannitol PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior or concurrent anti-myeloma therapy except steroids * Prior prednisone for ≤ 4 days at a total of 400 mg (or an equivalent potency of another steroid) allowed * No concurrent corticosteroids (≥ 10 mg prednisone/day or equivalent) other than dexamethasone * More than 4 weeks since prior major surgery and recovered * Prior kyphoplasty with oncotherapeutic drugs allowed at the investigator's discretion * More than 4 weeks since prior immunotherapy, antibody therapy, or radiotherapy * More than 14 days since other prior and no other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Oncotherapeutics: lead

Study Sites (12)

Arizona Clinical Research Center, Incorporated

Tucson, Arizona, 85712, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309-0633, United States

Location

San Diego Pacific Oncology and Hematology Associates, Incorporated - Escondido

Escondido, California, 92025, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Oncology Care Medical Associates - San Gabriel

Los Angeles, California, 90057, United States

Location

Desert Cancer Care

Rancho Mirage, California, 92270, United States

Location

Sutter Cancer Center at Roseville Medical Center

Roseville, California, 95661, United States

Location

Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara

Santa Barbara, California, 93105, United States

Location

James R. Berenson MD, Incorporated

West Hollywood, California, 90069, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Charleston Hematology Oncology Associates, PA

Charleston, South Carolina, 29403, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Bortezomib; Dexamethasone; Immunologic Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Investigative Techniques

Study Officials

• James R. Berenson, MD

  Oncotherapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 27, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2010
• Last Updated: December 18, 2013

Record last verified: 2010-06

Locations

US (12)