Bortezomib, Doxorubicin Hydrochloride Liposome, and Thalidomide as First-line Therapy in Treating Patients With Previously Untreated Stage I, II, or III Multiple Myeloma

NCT00523848 | Completed Phase 2 Results DMC

• 2 other identifiers: CDR0000563183RPCI-I-59105
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

• Overall Response Rate (Complete and Partial)

  Every 3 months

Secondary Outcomes (2)

• Complete Response Rate

  Every 3 months

• Time to Disease Progression

  Every 3 monthsntil the date of first documented progression or date of death from any cause, whichever came first

Study Arms (1)

Arm 1

EXPERIMENTAL

Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity

Drug: bortezomib; Drug: pegylated liposomal doxorubicin hydrochloride; Drug: thalidomide

Interventions

bortezomib DRUG

IV

Arm 1

pegylated liposomal doxorubicin hydrochloride DRUG

IV

Arm 1

thalidomide DRUG

Oral

Arm 1

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Karnofsky performance status 60-100%
• Platelet count ≥ 75,000 cells/mm\^3 (\< 75,000 cells/mm\^3 secondary to extensive bone marrow disease allowed at the PI's discretion with appropriate transfusion support)
• ANC ≥ 1,000 cells/mm\^3
• Hemoglobin ≥ 8.0 g/dL (\< 8 g/dL secondary to extensive bone marrow disease allowed at the PI's discretion with appropriate transfusion support)
• Creatinine clearance \> 20 mL/min
• AST and ALT ≤ 2 times upper limit of normal (ULN) OR ≤ 3 times ULN (in the presence of liver metastases)
• Alkaline phosphatase ≤ 2 times ULN OR ≤ 3 times ULN (in the presence of liver metastases)
• Total bilirubin ≤ 2 times ULN OR ≤ 3 times ULN (in the presence of liver metastases)
• Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram
• Negative pregnancy test
• Fertile patients must use at least 1 highly effective and 1 additional effective contraception method 4 weeks prior to, during, and 3 months after completion of study therapy
• HIV-negative
• Must have sufficient mental capacity to understand the explanation of the study and to provide informed consent
• Willingness and ability to comply with the FDA-mandated S.T.E.P.S. program

You may not qualify if:

• Pregnant or lactating
• Active, serious infections uncontrolled by antibiotics
• Any medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in this clinical trial
• History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or the components of doxorubicin hydrochloride liposome or bortezomib, boron, or mannitol
• Any of the following conditions:
• History of uncontrolled New York Heart Association class II-IV heart disease or clinical evidence of congestive heart failure
• Myocardial infarction within the past 6 months
• Uncontrolled angina
• Severe uncontrolled ventricular arrhythmias, ECG evidence of acute ischemia, or active conduction system abnormalities
• Peripheral neuropathy ≥ grade 2
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Bortezomib; Thalidomide

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; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Kelvin Lee, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 3, 2007
• Study Start: June 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2012
• Last Updated: February 23, 2017
• Results First Posted: September 17, 2013

Record last verified: 2017-01

Locations

US (1)