Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma and Plasma Cell Neoplasm

In brief

RATIONALE: Drugs used in chemotherapy such as cyclophosphamide 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. Giving cyclophosphamide and dexamethasone together with bortezomib may kill more cancer cells. PURPOSE: This phase II trial is studying giving cyclophosphamide and dexamethasone together with bortezomib to see how well it works in treating patients with newly diagnosed multiple myeloma.

Key facts

Study ID

NCT00609167

Run by

Mayo Clinic

People needed

63

Starts

2006-12-01

Expected to finish

2010-11-01

Last updated by the study team

2011-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
• ECOG PS of 3 will be allowed if secondary to pain in the opinion of the Investigator
• Total bilirubin normal OR direct bilirubin ≤ 2.0 mg/dL
• Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
• AST ≤ 3 times ULN
• Creatinine ≤ 3.5 mg/dL
• Absolute neutrophil count ≥ 1,000/mm³ without transfusion or growth factor
• Platelet count ≥ 100,000/mm³ without transfusion or growth factor
• Willingness and the physical and mental capability to provide written informed consent
• Willingness to return to Mayo Clinic Arizona/Princess Margaret Hospital for follow-up
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

You may not qualify if…

• Peripheral sensory neuropathy ≥ grade 2 as defined by National Cancer Institute (NCI) Common Terminology for Common Adverse Events (CTCAE) version 3.0
• Known hypersensitivity to compounds containing boron or mannitol
• Active uncontrolled infection
• Severe cardiac comorbidity including but not limited to:
• New York Heart Association class III or IV heart failure
• History of myocardial infarction within the past 6 months
• Uncontrolled angina or electrocardiographic (ECG) evidence of acute ischemia
• Severe uncontrolled ventricular arrhythmias or ECG evidence of active conduction system abnormalities
• Cardiac amyloidosis with hypotension (i.e., systolic blood pressure < 100 mm Hg)
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent study compliance or completion of study treatment
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Prior high-dose corticosteroid therapy for 12 days or less is permitted for emergent complications from newly diagnosed multiple myeloma
• More than 14 days since prior investigational agents
• No concurrent steroids or any other anticancer agents or treatments
• Patients may receive the equivalent of up to 20 mg prednisone per day for concurrent illness or adrenal replacement therapy
• Concurrent palliative radiotherapy for bony pain or fracture is allowed

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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