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Samarium Sm 153 Lexidronam Pentasodium and High-Dose Melphalan in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

sargramostim

melphalan

autologous hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

samarium Sm 153 lexidronam pentasodium

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Diagnosis of multiple myeloma requiring treatment
Must have at least 2 x 10^6 CD34+ cells collected for peripheral blood stem cell transplantation

PATIENT CHARACTERISTICS:

Inclusion criteria:

ECOG performance status (PS) 0-2 (ECOG PS > 2 allowed if secondary to neuropathy or acute bone event)
Direct bilirubin ≤ 2.0 mg/dL
Alkaline phosphatase ≤ 750 μ/L
Creatinine ≤ 3.0 mg/dL
Ejection fraction ≥ 45%
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception for 6 months after the completion of study therapy

Exclusion criteria:

DLCO < 50%
FVC < 50%
FEV_1 < 50%
Active malignancy with the exception of nonmelanoma skin cancer
Uncontrolled infection
NYHA class III-IV cardiac disease

PRIOR CONCURRENT THERAPY:

May or may not have received prior chemotherapy
At least 3 weeks since prior chemotherapy
- Cyclophosphamide pulsing for stem cell collection allowed
At least 4 weeks since prior biologic therapy
At least 2 weeks since prior bisphosphonates and bisphosphonates maybe resumed 1 month post-study treatment

Sites / Locations

Outcomes

Primary Outcome Measures

Number of toxicity incidents (Phase I)

Proportion of successes (Phase II)

Secondary Outcome Measures

Number of responses (Phase I)

Overall survival (Phase II)

Progression-free survival (Phase II)

Time to progression (Phase II)

Progressive disease variables

Full Information

NCT ID

NCT00602706

First Posted

January 15, 2008

Last Updated

May 13, 2011

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00602706

Brief Title

Samarium Sm 153 Lexidronam Pentasodium and High-Dose Melphalan in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant

Official Title

A Phase I/II Dose Escalation Study Assessing the Toxicity and Efficacy of 153-Samarium-EDTMP in Place of TBI in the Conditioning Regimen for PBSCT for Patients With Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

January 2000 (undefined)

Primary Completion Date

June 2003 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Samarium Sm 153 lexidronam pentasodium contains a radioactive substance that kill cancer cells. Peripheral blood stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy and radioactive drugs used to kill cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with high-dose melphalan in treating patients with multiple myeloma undergoing stem cell transplant.

Detailed Description

OBJECTIVES: To find the maximum tolerated dose of samarium Sm 153 lexidronam pentasodium when given with fixed high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplantation in patients with multiple myeloma. (Phase I) To assess the response rates of this regimen in these patients. (Phase II) OUTLINE: This is a phase I, dose-escalation study of samarium Sm 153 lexidronam pentasodium followed by a phase II study. Phase I: Patients receive samarium Sm 153 lexidronam pentasodium IV once between days -14 and -10. Patients also receive melphalan IV on day -1. Patients undergo peripheral blood stem cell transplantation on day 0. Patients receive sargramostim (GM-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover. Phase II: Patients receive samarium Sm 153 lexidronam pentasodium at the MTD determined in phase I . Blood samples are collected periodically to determine clearance of samarium Sm 153 lexidronam pentasodium and bone marrow dosimetry.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

sargramostim

Intervention Type

Drug

Intervention Name(s)

melphalan

Intervention Type

Procedure

Intervention Name(s)

autologous hematopoietic stem cell transplantation

Intervention Type

Procedure

Intervention Name(s)

peripheral blood stem cell transplantation

Intervention Type

Radiation

Intervention Name(s)

samarium Sm 153 lexidronam pentasodium

Primary Outcome Measure Information:

Title

Number of toxicity incidents (Phase I)

Title

Proportion of successes (Phase II)

Secondary Outcome Measure Information:

Title

Number of responses (Phase I)

Title

Overall survival (Phase II)

Title

Progression-free survival (Phase II)

Title

Time to progression (Phase II)

Title

Progressive disease variables

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma requiring treatment Must have at least 2 x 10^6 CD34+ cells collected for peripheral blood stem cell transplantation PATIENT CHARACTERISTICS: Inclusion criteria: ECOG performance status (PS) 0-2 (ECOG PS > 2 allowed if secondary to neuropathy or acute bone event) Direct bilirubin ≤ 2.0 mg/dL Alkaline phosphatase ≤ 750 μ/L Creatinine ≤ 3.0 mg/dL Ejection fraction ≥ 45% Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 6 months after the completion of study therapy Exclusion criteria: DLCO < 50% FVC < 50% FEV_1 < 50% Active malignancy with the exception of nonmelanoma skin cancer Uncontrolled infection NYHA class III-IV cardiac disease PRIOR CONCURRENT THERAPY: May or may not have received prior chemotherapy At least 3 weeks since prior chemotherapy Cyclophosphamide pulsing for stem cell collection allowed At least 4 weeks since prior biologic therapy At least 2 weeks since prior bisphosphonates and bisphosphonates maybe resumed 1 month post-study treatment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angela Dispenzieri, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

Samarium Sm 153 Lexidronam Pentasodium and High-Dose Melphalan in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant

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