Doxorubicin Hydrochloride Liposome, Melphalan, and Bortezomib in Treating Patients With Relapsed or Refractory Stage I, Stage II, or Stage III Multiple Myeloma

NCT00334932 | Unknown Phase 1

• 2 other identifiers: CDR0000471769CPMC-AAAB6443
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and melphalan, 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. Giving doxorubicin hydrochloride liposome and melphalan together with bortezomib may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of doxorubicin hydrochloride liposome , melphalan, and bortezomib and to see how well they work in treating patients with relapsed or refractory stage I, stage II, or stage III multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients experiencing treatment-related ≥ grade 3 hematologic or nonhematologic toxicity or treatment-related death (phase I)

Secondary Outcomes (4)

• Time to response (phase II)

• Progression-free survival (phase II)

• Overall survival (phase II)

• Toxicities by NCI criteria (phase II)

Interventions

bortezomib DRUG

melphalan DRUG

pegylated liposomal doxorubicin hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Stage I, II, or III disease according to Durie-Salmon staging criteria * Progressive disease, defined as one of the following: * For secretory disease: * A 25% increase in serum M-protein or Bence Jones protein (an absolute increase of 0.5 g/dL serum M-protein or ≥ 200 mg/24 hours of urine light chain excretion) * For nonsecretory disease: * Bone marrow biopsy with \> 25% increase in plasma cells or an absolute increase of ≥ 10% over prior known level * Development of new or worsening existing lytic bone lesions or soft tissue plasmacytomas * Hypercalcemia (i.e., calcium \> 11.5 mg/dL) * Relapsed after complete response * Must have received ≥ 2 of the following therapeutic regimens for multiple myeloma: * Nonmyeloablative transplantation * No significant graft-versus-host disease * At least 30 days since prior immunosuppressive therapy (concurrent prednisone allowed provided dose is ≤ 10 mg daily) * Mobilization with chemotherapy followed by either single or tandem autologous stem cell transplantation (considered 1 prior regimen) * Mobilization with chemotherapy followed by autologous and subsequent nonmyeloablative allogeneic stem cell transplantation (considered 1 prior regimen) * Any combination of drugs given concurrently (considered 1 prior regimen) PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Absolute neutrophil count \> 1,000/mm\^3 (no colony-stimulating factors) * Platelet count \> 50,000/mm\^3 (no transfusion support) * Bilirubin ≤ 2.0 mg/dL * AST ≤ 4 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment * No history of allergic reaction to compounds containing boron or mannitol * No active uncontrolled viral (including HIV), bacterial, or fungal infection * No motor or sensory neuropathy ≥ grade 2 * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart failure * No uncontrolled angina * No severe uncontrolled arrhythmia * No acute ischemia by EKG * LVEF ≥ 35% by MUGA (MUGA required in patients whose lifetime cumulative doxorubicin hydrochloride dose \> 400 mg/m\^2) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No grade III or IV toxicity due to previous antineoplastic therapy (except alopecia) * At least 3 weeks since prior chemotherapy * No prior doxorubicin HCl liposome, melphalan, and bortezomib as combination therapy (single or two-drug combinations of these are allowed) * No concurrent corticosteroids (≤ 10 mg prednisone/day or equivalent allowed) * No other concurrent chemotherapy * No concurrent thalidomide * No other concurrent investigational therapy * No other concurrent antineoplastic treatment for multiple myeloma, including clarithromycin * No concurrent radiation therapy * No concurrent nonsteroidal anti-inflammatory agents

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

Sponsors & Collaborators

• Herbert Irving Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

RECRUITING

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (1)

• Chari A, Kaplan L, Linker C, et al.: Phase I/II study of bortezomib in combination with liposomal doxorubicin and melphalan in relapsed or refractory multiple myeloma. [Abstract] Blood 106 (11): A-5182, 2005 .

  RESULT

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Bortezomib; Melphalan

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; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ajai Chari, MD

  Herbert Irving Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 7, 2006
• First Posted: June 8, 2006
• Study Start: February 1, 2006
• Primary Completion: January 1, 2010
• Last Updated: January 10, 2014

Record last verified: 2008-08

Locations

US (2)