Working... Menu
Trial record 58 of 2516 for:    "Plasma Cell Neoplasm"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00602706
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : May 16, 2011
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

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.

Condition or disease Intervention/treatment 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

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
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
Study Start Date : January 2000
Actual Primary Completion Date : June 2003
Actual Study Completion Date : July 2010

Primary Outcome Measures :
  1. Number of toxicity incidents (Phase I)
  2. Proportion of successes (Phase II)

Secondary Outcome Measures :
  1. Number of responses (Phase I)
  2. Overall survival (Phase II)
  3. Progression-free survival (Phase II)
  4. Time to progression (Phase II)
  5. Progressive disease variables

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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


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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00602706

Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Angela Dispenzieri, MD Mayo Clinic

Layout table for additonal information
Responsible Party: Angela Dispenzieri, M.D., Mayo Clinic Cancer Center Identifier: NCT00602706     History of Changes
Other Study ID Numbers: CDR0000582552
P30CA015083 ( U.S. NIH Grant/Contract )
MC9981 ( Other Identifier: Mayo Clinic Cancer Center )
1046-99 ( Other Identifier: Mayo Clinic IRB )
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011

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

Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Samarium Sm-153 lexidronam
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents