Trials Sponsors Conditions Drugs Pricing

Conditions

Multiple Myeloma and Plasma Cell Neoplasm Pain

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myelomapain

Outcome Measures

Primary Outcomes (2)

Toxicity (Phase I)
12 weeks
Confirmed clinical response of serum and urine monoclonal protein (Phase II)
12 weeks

Secondary Outcomes (3)

Response (Phase I)
12 weeks
Bone pain response (Phase II)
12 weeks
Toxicity (Phase II)
12 weeks

Study Arms (1)

Sm 153 lexidronam

EXPERIMENTAL

Drug: PamidronateDrug: Zoledronic acidRadiation: Sm 153 lexidronam

Interventions

PamidronateDrug

90 mg by IV monthly.

Also known as: Aredia

Sm 153 lexidronam

Zoledronic acidDrug

4 mg by IV monthly.

Also known as: Zometa

Sm 153 lexidronam

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Relapsed or refractory disease, meeting 1 of the following criteria: * Recurrent disease after stem cell transplantation * Recurrent or progressive disease despite treatment with ≥ 1 standard regimen (e.g., an alkylating agent plus glucocorticoid and/or the combination of vincristine, doxorubicin hydrochloride, and dexamethasone) * Measurable or evaluable disease, defined by at least 1 of the following: * Monoclonal protein ≥ 1.0 g by serum 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) * Patients must have already undergone hematopoietic stem cell collection, if believed to be a transplant candidate OR not eligible for a hematopoietic stem cell transplant PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if secondary to pain) * ANC ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL (transfusions allowed) * 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 active malignancy except for nonmelanoma skin cancer or carcinoma in situ of the cervix or breast * No uncontrolled infection * No other co-morbidity that would interfere with the patient's ability to participate in this trial * No known hypersensitivity to any of the components of samarium Sm 153 lexidronam pentasodium or bisphosphonates PRIOR CONCURRENT THERAPY: * Recovered from all prior surgery, radiotherapy, or other antineoplastic therapy * More than 4 weeks since prior melphalan or other myelosuppressive agents * More than 2 weeks since prior nonmyelosuppressive agents (e.g., thalidomide or high-dose corticosteroids) * More than 30 days since prior and no other concurrent investigational therapy * No prior samarium Sm 153 lexidronam pentasodium or strontium chloride Sr 89 * No concurrent external beam radiotherapy * No concurrent high-dose corticosteroids * Concurrent chronic steroids (maximum dose of 20 mg/day prednisone equivalent) allowed for disorders other than myeloma (i.e., adrenal insufficiency or rheumatoid arthritis) * Low-dose steroids allowed for replacement or inhalation therapy * No other concurrent medications, including any of the following: * Cytotoxic chemotherapy * Systemic antineoplastic therapy including, but not limited to, immunotherapy, hormonal therapy, or monoclonal antibody therapy * Prophylactic hematopoietic growth factors * Hematopoietic growth factors allowed for established cytopenia therapy

Sponsors & Collaborators

Mayo Clinic
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma CellPain

Interventions

PamidronateZoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

Angela Dispenzieri, M.D.
Mayo Clinic
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 4, 2007

First Posted

June 5, 2007

Study Start

March 21, 2005

Actual (reported)

Primary Completion

May 22, 2007

Actual (reported)

Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

Sm 153 lexidronam

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

Sm 153 lexidronam

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations