Clinical trial · Interventional
Melphalan and Stem Cell Transplant Before Total-Body Irradiation and Donor Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma
Allogeneic Stem Cell Transplantation For Multiple Myeloma: A Two Step Approach To Reduce Toxicity Involving High Dose Melphalan and Autologous Stem Cell Transplant Followed By PBSC Allografting After Low Dose TBI
NCT00003954CI-TRIAL-00043234completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
In this study donor bone marrow transplantation is divided into a two step process to try to significantly reduce the side effects of the procedure yet still provide patients with multiple myeloma the benefits of this procedure
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage III Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage II Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage I Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| cyclosporine | Drug | — | UNRESOLVED |
| melphalan | Drug | Melphalan | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
| total-body irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (Melphalan and PBSCT before TBI and Donor PBSCT)
- description
- CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 15-20 minutes on day -2. TRANSPLANTATION: Patients undergo autologous bone marrow or PBSCT on day 0. NON-MYELOABLATIVE CONDITIONING REGIMEN: Beginning 40-120 days after autologous transplant, patients undergo TBI on day 0. TRANSPLANTATION: Patients undergo donor PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV BID on days -1 and 0 and PO BID on days 1-80 with taper based on evaluation of disease response and GVHD. Patients also receive mycophenolate mofetil PO BID on days 0-27. POST TRANSPLANT DLI: Beginning 4 weeks after immunosuppression, patients achieving persistent or progressive disease may undergo DLI over 30 minutes every 4 weeks for up to 3 treatments.
- interventionNames
- Drug: melphalan
- Procedure: autologous hematopoietic stem cell transplantation
- Procedure: autologous bone marrow transplantation
- Procedure: peripheral blood stem cell transplantation
- Radiation: total-body irradiation
- Drug: cyclosporine
- Drug: mycophenolate mofetil
- Biological: therapeutic allogeneic lymphocytes
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Meet Salmon and Durie criteria for initial diagnosis of multiple myeloma; transplant will be offered to patients with stage II or III multiple myeloma (MM) at diagnosis or have received chemotherapy and/or radiation therapy for progressive MM after initial diagnosis of stage I disease * The patient must have the capacity to give informed consent * Have received at least 4 cycles of conventional dose chemotherapy for MM * DONOR: HLA genotypically identical sibling * DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis for both peripheral blood stem cell (PBSC) allograft and subsequent DLI * DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian) * DONOR: Age \< 75, older donors may be considered after consultation by Psychological Consultation Center (PCC) Exclusion Criteria: * Karnofsky score less than 60, unless due solely to myeloma * Left ventricular ejection fraction less than 40% * Bilirubin greater than 2 X the upper limit of normal * Serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) \> 2 X the upper limit of normal * Diffusion lung capacity of carbon monoxide (DLCO) \< 50% (corrected) or receiving continuous supplemental oxygen * Patients with poorly controlled hypertension * Pregnancy * Seropositive for the human immunodeficiency virus * Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment * Creatinine clearance \< 40 cc/min at the time of initial autografting evaluation * Prior autograft (can be treated on alternative protocol) * DONOR: Identical twin * DONOR: Age less than 12 years * DONOR: Pregnancy * DONOR: Infection with human immunodeficiency virus (HIV) * DONOR: Inability to achieve adequate venous access * DONOR: Known allergy to G-CSF * DONOR: Current serious systemic illness * DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) criteria for stem cell donation as described in the standard practice guidelines of the institution
References
Publications (1)
- DERIVEDCooper JP, Storer BE, Granot N, Gyurkocza B, Sorror ML, Chauncey TR, Shizuru J, Franke GN, Maris MB, Boyer M, Bruno B, Sahebi F, Langston AA, Hari P, Agura ED, Lykke Petersen S, Maziarz RT, Bethge W, Asch J, Gutman JA, Olesen G, Yeager AM, Hubel K, Hogan WJ, Maloney DG, Mielcarek M, Martin PJ, Flowers MED, Georges GE, Woolfrey AE, Deeg JH, Scott BL, McDonald GB, Storb R, Sandmaier BM. Allogeneic hematopoietic cell transplantation with non-myeloablative conditioning for patients with hematologic malignancies: Improved outcomes over two decades. Haematologica. 2021 Jun 1;106(6):1599-1607. doi: 10.3324/haematol.2020.248187. PMID 32499241