Samarium Sm 153 Lexidronam Pentasodium and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT00478075 | Completed Phase 1

• 4 other identifiers: CDR0000546736P30CA015083MC05851586-05
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to cancer cells and not harm normal cells. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Bortezomib may also make cancer cells more sensitive to radiation therapy. Giving samarium Sm 153 lexidronam pentasodium together with bortezomib may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with samarium Sm 153 lexidronam pentasodium and to see how well they work in treating patients with relapsed or refractory multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Toxicity (Phase I)

• Confirmed clinical response (complete response, very good partial response, partial response, or minimal response) (Phase II)

Secondary Outcomes (2)

• Immunoglobulin free light chain response

• Changes in complete blood cell count and micronucleated reticulocyte count

Interventions

bortezomib DRUG

immunologic technique OTHER

samarium Sm 153 lexidronam pentasodium RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Relapsed or refractory disease * Measurable or evaluable disease as defined by at least 1 of the following: * Serum monoclonal protein ≥ 1.0 g by protein electrophoresis * Monoclonal protein ≥ 200 mg by 24-hour urine electrophoresis * Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio * Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease) * Previously treated disease * No limit to prior therapy provided there is adequate residual organ function * Must have undergone hematopoietic stem cell collection (for transplant candidates) OR not considered to be a hematopoietic stem cell transplant candidate PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 (ECOG PS of 3 allowed if secondary only to pain) * Platelet count ≥ 75,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL (transfusion allowed) * ANC ≥ 1,000/mm\^3 * Creatinine ≤ 3 mg/dL * Calcium ≤ 15 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 weeks after completion of study therapy * No impending long bone fracture * No other active malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or breast cancer * No uncontrolled infection * No known hypersensitivity to any of the components of study drugs * No other co-morbidity that would preclude study participation PRIOR CONCURRENT THERAPY: * Recovered from prior surgery, radiotherapy, or other antineoplastic therapy * No prior samarium Sm 153 lexidronam pentasodium or strontium chloride Sr 89 * At least 3 weeks since prior myelosuppressive agents * At least 2 weeks since prior nonmyelosuppressive agents (e.g., thalidomide) * At least 2 weeks since prior and no concurrent high-dose corticosteroids * Chronic steroids (maximum dose of 20 mg/day prednisone or equivalent) allowed for disorders other than myeloma (i.e., adrenal insufficiency or rheumatoid arthritis) * At least 30 days since prior and no other concurrent investigational therapy * No concurrent external beam radiotherapy * No concurrent cytotoxic chemotherapy * No other concurrent systemic antineoplastic therapy including, but not limited to, any of the following: * Immunotherapy * Hormonal therapy * Monoclonal antibody therapy

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Bortezomib; Immunologic Techniques; samarium Sm-153 lexidronam

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; Investigative Techniques

Study Officials

• Angela Dispenzieri, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 23, 2007
• First Posted: May 24, 2007
• Study Start: September 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: June 1, 2009
• Last Updated: May 11, 2011

Record last verified: 2011-05

Locations

US (3)