Clinical trial · Interventional
Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
A Phase II Trial Of Autologous Stem Cell Transplant Followed By Mini-Allogeneic Stem Cell Transplant In Lieu Of Standard Allogeneic Bone Marrow Transplantation For Treatment Of 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 use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells are rejected by the body's tissues. Peripheral stem cell transplantation with the person's own stem cells followed by donor peripheral stem cell transplantation may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with autologous peripheral stem cell transplantation and donor peripheral stem cell transplantation in treating patients who have multiple myeloma.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma meeting 1 of the following criteria:
* Bone marrow plasmacytosis with at least 10% plasma cells
* Sheets of plasma cells
* Biopsy-proven plasmacytoma
* Meets at least 1 of the following criteria:
* Presence of myeloma (M)-protein in the serum
* Presence of M-protein in the urine
* Radiographic evidence of osteolytic lesions
* Generalized osteoporosis allowed if at least 20% plasma cells in bone marrow
* No non-secretory myeloma
* Prior M-protein in serum or urine allowed provided patient is now in complete remission
* Must be receiving conventional-dose chemotherapy as initial therapy or as salvage therapy
* Must have HLA-A, -B, and -DR genotypically identical sibling donor
PATIENT CHARACTERISTICS:
Age:
* 18 to 70
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* AST no greater than 3 times upper limit of normal
* Bilirubin less than 2.0 mg/dL
Renal:
* Not specified
Cardiovascular:
* LVEF greater than 40% at rest if symptomatic cardiac disease is present
Pulmonary:
* DLCO greater than 50% of predicted (corrected for hemoglobin) if symptomatic pulmonary disease is present
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior autologous or allogeneic peripheral blood stem cell or bone marrow transplantation
Chemotherapy:
* See Disease Characteristics
* More than 28 days since prior chemotherapy (including primary chemotherapy for hematopoietic stem cell collection)
* No other concurrent cytotoxic chemotherapy between autologous and allogeneic transplantation
Endocrine therapy:
* Prior dexamethasone or other corticosteroids allowed
* Concurrent corticosteroids between autologous and allogeneic transplantation allowed
Radiotherapy:
* Concurrent radiotherapy between autologous and allogeneic transplantation allowed
Surgery:
* Not specifiedReferences
Publications (1)
- BACKGROUNDVesole DH, Zhang L, Flomenberg N, Greipp PR, Lazarus HM, Huff CA; ECOG Myeloma and BMT Committees. A Phase II trial of autologous stem cell transplantation followed by mini-allogeneic stem cell transplantation for the treatment of multiple myeloma: an analysis of Eastern Cooperative Oncology Group ECOG E4A98 and E1A97. Biol Blood Marrow Transplant. 2009 Jan;15(1):83-91. doi: 10.1016/j.bbmt.2008.10.030. PMID 19135946