Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| samarium Sm 153 lexidronam pentasodium | Radiation | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Number of toxicity incidents (Phase I)
- measure
- Proportion of successes (Phase II)
Secondary outcomes (5)
- measure
- Number of responses (Phase I)
- measure
- Overall survival (Phase II)
- measure
- Progression-free survival (Phase II)
- measure
- Time to progression (Phase II)
- measure
- Progressive disease variables
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available