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

NCT00983346 | Terminated Phase 2 Results DMC

• 1 other identifier: HCI33979
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Myeloma; Multiple Myeloma

Keywords

cancer; myeloma; multiple myeloma; smoldering myeloma

Outcome Measures

Primary Outcomes (1)

• Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.

  The primary endpoint is the change in bone Alkaline Phosphatase at baseline and 6 weeks.

  Baseline and 6 weeks

Study Arms (1)

All patients

EXPERIMENTAL

All participants enrolled.

Drug: Bortezomib

Interventions

Bortezomib DRUG

Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle. Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle.

Also known as: Velcade

All patients

Eligibility Criteria

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

You may qualify if:

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to participation in the study and any related procedures being performed) with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasms, Plasma Cell; Multiple Myeloma; Smoldering Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; 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; Precancerous Conditions; Hypergammaglobulinemia

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Mark Wade
• Organization: Huntsman Cancer Institute

mark.wade@hci.utah.edu

801-213-5746

Study Officials

• Maurizio Zangari, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 24, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: July 11, 2016
• Results First Posted: November 30, 2015

Record last verified: 2016-07

Locations

US (1)