Clinical trial · Interventional
Autologous Transplant for Multiple Myeloma
Autologous Transplantation for Multiple Myeloma
NCT00177047CI-TRIAL-00054956completedPhase 2 / Phase 3Results postedClinicalTrials.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)
This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.
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 | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide + Mesna | Drug | — | UNRESOLVED |
| Granulocyte-colony stimulating factor | Biological | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Stem Cell Transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy and Transplant Treatment
- description
- Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.
- interventionNames
- Procedure: Stem Cell Transplant
- Drug: Cyclophosphamide + Mesna
- Drug: Melphalan
- Biological: Granulocyte-colony stimulating factor
Primary outcomes (3)
- measure
- Number of Participants Achieving a Complete Response
- timeFrame
- 100 Days post transplant
- description
- Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following: * After initial therapy in either first complete or partial remission or no objective response * After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response * Is not eligible or has refused any protocols of higher priority * 18 - 75 years of age * Adequate organ function defined as: * Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused) * Cardiac: no active ischemia, left ventricular ejection fraction \> 45% by MUGA scan * Hepatic: bilirubin \< 2.0 mg/dl, ALT \< 3x the upper limit of normal * Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) \>50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) \> 50% predicted * Performance status: Karnofsky performance of \> 80%. * Free of active uncontrolled infection at the time of study entry. * At time of study enrollment \> 4 weeks from prior myelosuppressive chemotherapy; and \> 6 weeks from prior nitrosoureas. * Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee. Exclusion Criteria: * Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens. * Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.
References
Publications (0)
Data not yet available
No reference posted for this study.