NCT00482378

Brief Summary

RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to cancer cells and not harm normal cells. Zoledronic acid and pamidronate may help relieve bone pain caused by multiple myeloma. Giving samarium Sm 153 lexidronam pentasodium together with zoledronic acid or pamidronate may be an effective treatment for multiple myeloma. PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with zoledronic acid or pamidronate and to see how well it works in treating patients with relapsed or refractory multiple myeloma and bone pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2008

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

2.2 years

First QC Date

June 4, 2007

Last Update Submit

August 13, 2018

Conditions

Multiple Myeloma and Plasma Cell NeoplasmPain

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
Sm 153 lexidronamRADIATION

0.5 mCi/kg or 1 mCi/kg by IV.

Also known as: Sm 153 lexidronam consists of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP).
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

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

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

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 DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Angela Dispenzieri, M.D.

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
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

Primary Completion

May 22, 2007

Study Completion

December 2, 2008

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations

US(1)