Samarium Sm 153 Lexidronam Pentasodium and High-Dose Melphalan in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant
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
4 other identifiers
interventional
76
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2000
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 15, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedMay 16, 2011
May 1, 2011
3.4 years
January 15, 2008
May 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of toxicity incidents (Phase I)
Proportion of successes (Phase II)
Secondary Outcomes (5)
Number of responses (Phase I)
Overall survival (Phase II)
Progression-free survival (Phase II)
Time to progression (Phase II)
Progressive disease variables
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Cancer Institute (NCI)collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Angela Dispenzieri, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 15, 2008
First Posted
January 28, 2008
Study Start
January 1, 2000
Primary Completion
June 1, 2003
Study Completion
July 1, 2010
Last Updated
May 16, 2011
Record last verified: 2011-05