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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| MC9981 | Other Identifier | Mayo Clinic Cancer Center | |
| 1046-99 | Other Identifier | Mayo Clinic IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
OUTLINE: This is a phase I, dose-escalation study of samarium Sm 153 lexidronam pentasodium followed by a phase II study.
Blood samples are collected periodically to determine clearance of samarium Sm 153 lexidronam pentasodium and bone marrow dosimetry.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sargramostim | Biological | |||
| melphalan | Drug | |||
| autologous hematopoietic stem cell transplantation | Procedure | |||
| peripheral blood stem cell transplantation | Procedure | |||
| samarium Sm 153 lexidronam pentasodium | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of toxicity incidents (Phase I) | ||
| Proportion of successes (Phase II) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of responses (Phase I) | ||
| Overall survival (Phase II) | ||
| Progression-free survival (Phase II) |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
May or may not have received prior chemotherapy
At least 3 weeks since prior chemotherapy
At least 4 weeks since prior biologic therapy
At least 2 weeks since prior bisphosphonates and bisphosphonates maybe resumed 1 month post-study treatment
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| Name | Affiliation | Role |
|---|---|---|
| Angela Dispenzieri, MD | Mayo Clinic | Study Chair |
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| Time to progression (Phase II) |
| Progressive disease variables |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C081222 | sargramostim |
| D008558 | Melphalan |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| C061972 | samarium Sm-153 lexidronam |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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