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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00602706
First received: January 15, 2008
Last updated: May 13, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
 Biological: sargramostim
Drug: melphalan
Procedure: autologous hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: samarium Sm 153 lexidronam pentasodium
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of toxicity incidents (Phase I) [ Designated as safety issue: Yes ]
  • Proportion of successes (Phase II) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of responses (Phase I) [ Designated as safety issue: No ]
  • Overall survival (Phase II) [ Designated as safety issue: No ]
  • Progression-free survival (Phase II) [ Designated as safety issue: No ]
  • Time to progression (Phase II) [ Designated as safety issue: No ]
  • Progressive disease variables [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: January 2000
Study Completion Date: July 2010
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602706

Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: Angela Dispenzieri, MD Mayo Clinic
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Angela Dispenzieri, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00602706     History of Changes
Other Study ID Numbers: CDR0000582552, P30CA015083, MC9981, 1046-99
Study First Received: January 15, 2008
Last Updated: May 13, 2011
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
 Melphalan
Samarium ethylenediaminetetramethylenephosphonate
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on May 23, 2013