Clinical trial · Interventional
Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma
NCT00028600CI-TRIAL-00022835completedPhase 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)
RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma.
Conditions
Conditions (2)
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 | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Plasma Cell Neoplasm | Plasma Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD34+ cells | Biological | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous + Allogeneic Transplant
- description
- autologous PB stem cell transplant followed by non-myeloablative allogeneic transplant fr multiple myeloma
- interventionNames
- Biological: filgrastim
- Biological: CD34+ cells
- Drug: cyclophosphamide
- Drug: fludarabine phosphate
- Drug: melphalan
- Drug: methotrexate
- Drug: tacrolimus
Primary outcomes (1)
- measure
- Treatment-related mortality
- timeFrame
- 6 months
Secondary outcomes (6)
- measure
- Treatment Completion Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of active multiple myeloma that requires treatment * Durie-Salmon stage I, II, and III * No more than 1 progression after initial therapy * Must have HLA-identical sibling donor (6/6) by serologic typing (A, B, DR) * No syngeneic donors * Must also be enrolled on protocol CLB-8461 (Cytogenetic Studies in Acute Leukemia) PATIENT CHARACTERISTICS: Age: * Under 65 Performance status: * NCI CTC 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 500/mm\^3 * Platelet count greater than 50,000/mm\^3 Hepatic: * Bilirubin less than 2 mg/dL * AST less than 3 times upper limit of normal (ULN) * Alkaline phosphatase less than 3 times ULN Renal: * Creatinine less than 2 mg/dL * Creatinine clearance greater than 40 mL/min Cardiovascular: * LVEF at least 30% by MUGA scan Pulmonary: * DLCO greater than 40% of predicted * No symptomatic pulmonary disease Other: * HIV negative * No uncontrolled diabetes mellitus * No active serious infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy * Prior alkylating-agent therapy allowed if no more than 12 months duration Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * At least 4 weeks since prior surgery Other: * All prior therapy no more than 18 months duration
References
Publications (1)
- DERIVEDHolstein SA, Suman VJ, Owzar K, Santo K, Benson DM Jr, Shea TC, Martin T, Silverman M, Isola L, Vij R, Cheson BD, Linker C, Anderson KC, Richardson PG, McCarthy PL. Long-Term Follow-up of CALGB (Alliance) 100001: Autologous Followed by Nonmyeloablative Allogeneic Transplant for Multiple Myeloma. Biol Blood Marrow Transplant. 2020 Aug;26(8):1414-1424. doi: 10.1016/j.bbmt.2020.03.028. Epub 2020 Apr 20. PMID 32325171