Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients

• Status: Terminated
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES

• Primary: To evaluate the bone anabolic effect of bortezomib in patients with smoldering myeloma.

• Secondary: To evaluate the effect of bortezomib on the natural history of smoldering myeloma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: Millennium Pharmaceuticals, Inc.
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• Patients with diagnosis of smoldering multiple myeloma

• Male or Female patients aged ≥ 18 years old

• Ability to provide written informed consent (obtained prior to participation in the study and any related procedures being performed) with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study

• Male subject agrees to use an acceptable method for contraception for the duration of the study.

• Serum M protein ≥3 g/dL and/or

• Bone marrow plasma cells ≥10%

• Absence of anemia, renal failure, hypercalcemia, and lytic bone lesions

• ANC ≥ 1.5 x 109 /L

• Hemoglobin ≥ 10g/dl

• Platelets ≥ 100 x 109 /L

• AST and ALT ≤2.5 x ULN

• Serum bilirubin ≤2.0 x ULN

Exclusion Criteria:

• Platelet count of <100 109/L within 14 days before enrollment.

• Absolute neutrophil count of <1.0 109/L within 14 days before enrollment.

• Creatinine clearance of <30 mL/minute within 14 days before enrollment.

• Patient has Grade 2 peripheral neuropathy within 14 days before enrollment.

• Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.

• Patient has hypersensitivity to bortezomib, boron or mannitol.

• Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.

• Patient has received other investigational drugs with 14 days before enrollment

• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

• Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.

• Patients currently taking bisphosphonates