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Updated: Aug 21, 2026
Percutaneous Hepatic Perfusion (PHP) with Melphalan as a Treatment for Unresectable Metastases Confined to the Liver
Published on: July 31, 2016
A phase I study of 153Sm-EDTMP with fixed high-dose melphalan as a peripheral blood stem cell conditioning regimen in
A Dispenzieri1, G A Wiseman, M Q Lacy
1Department of Internal Medicine, Division of Hematology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. dispenzieri.angela@mayo.edu
Abstract:
Despite response rates of 30% after high-dose chemotherapy with autologous hematopoietic stem cell transplant, patients with multiple myeloma are not cured. 153Samarium ethylenediaminetetramethylenephosphonate (153Sm-EDTMP; Quadramet) is a short-range, beta-emitting therapeutic radiopharmaceutical with avid skeletal uptake. In total, 12 patients were treated with escalating doses of 153Sm-EDTMP (N=3/group; 6, 12, 19.8, and 30 mCi/kg) and a fixed dose of melphalan (200 mg/m(2)). No dose limiting toxicity was seen. To better standardize the marrow compartment radiation dose, the study was modified such that an additional six patients were treated at a targeted absorbed radiation dose to the red marrow of 40 Gy based on a trace labeled infusion 1 week prior to the therapy. Despite rapid elimination of unbound radiopharmaceutical via kidneys and bladder, no episodes of nephrotoxicity, hemorrhagic cystitis, or delayed radiation nephritis were observed with a median follow-up of 31 months (range 8.5-44). Median times to ANC>0.5 and platelet >20 x 10(6)/l were 12 and 11 days, respectively, with no graft failures. Overall response rate was 94% including seven very good partial responses and five complete responses. Addition of 153Sm EDTMP to melphalan conditioning appears to be safe, well-tolerated and worthy of further study.
Insights
Adding therapeutic radiopharmaceutical 153Samarium ethylenediaminetetramethylenephosphonate (153Sm-EDTMP) to melphalan conditioning for multiple myeloma is safe and effective. This combination shows a high response rate with manageable toxicity, warranting further investigation.
Area of Science:
- Oncology
- Nuclear Medicine
- Hematology
Background:
- High-dose chemotherapy with autologous hematopoietic stem cell transplant (HCT) offers limited cure rates for multiple myeloma.
- 153Samarium ethylenediaminetetramethylenephosphonate (153Sm-EDTMP) is a radiopharmaceutical with skeletal uptake, suitable for targeted radiation therapy.
Purpose of the Study:
- To evaluate the safety and efficacy of escalating doses of 153Sm-EDTMP combined with melphalan conditioning in multiple myeloma patients.
- To assess the toxicity profile and response rates of this combined conditioning regimen.
Main Methods:
- A dose-escalation study involving 12 patients treated with 153Sm-EDTMP (6-30 mCi/kg) and a fixed dose of melphalan (200 mg/m2).
- A modified protocol for six additional patients targeted a 40 Gy absorbed radiation dose to red marrow using trace-labeled infusion prior to therapy.
- Median follow-up was 31 months.
Main Results:
- No dose-limiting toxicities were observed across escalating doses.
- No nephrotoxicity, hemorrhagic cystitis, or delayed radiation nephritis were reported.
- Overall response rate was 94%, with seven very good partial responses and five complete responses.
- Median times to neutrophil and platelet recovery were 12 and 11 days, respectively, with no graft failures.
Conclusions:
- The addition of 153Sm-EDTMP to melphalan conditioning is safe and well-tolerated in multiple myeloma.
- This combination demonstrates a high overall response rate and favorable hematologic recovery.
- Further clinical studies are warranted to explore the full potential of 153Sm-EDTMP in multiple myeloma treatment.
