Clinical trial · Interventional
Busulfan and Melphalan Conditioning in Multiple Myeloma
A Phase 2, Open-label, Prospective, Multicenter Study to Evaluate the Efficacy of Intravenous Busulfan and Melphalan as a Conditioning Regimen in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation
NCT01923935CI-TRIAL-00011795unknownPhase 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)
The purpose of this study is to determine whether intravenous busulfan and melphalan as a conditioning regimen is effective in the treatment of multiple myeloma undergoing autologous stem cell transplantation.
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 (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BUSULFEX®, Alkeran®
- description
- BUSULFEX® 3.2 mg/kg/day iv once daily over 3 hours (day-6\~day-4) Alkeran® 70 mg/m2/day iv once daily over 30 minutes (day-3\~day-2)
- interventionNames
- Drug: BUSULFEX®
- Drug: Alkeran®
Primary outcomes (2)
- measure
- Treatment response up to 2 months after ASCT
- timeFrame
- 2 months later after last patent received ASCT
- description
- 1. To evaluate the objective responses after ASCT, the guidelines from the International Myeloma Working (IMW) Group uniform response criteria will be used. 2. Serum free light chain study will be added at the every evaluation of response. 3. To confirm the stringent complete response (sCR) after ASCT, flow cytometry or immunohistochemistry will be used Response Criteria for Multiple Myeloma: the guidelines from the IMW Group uniform response criteria + Add for criteria of near CR (Immunofixation positive CR)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a confirmed diagnosis of MM * Symptomatic MM * Age 20 - 65 years * The MM patients who performed the stem cell collection with appropriate stem cell counts, cluster of differentiation 34 positive cells more than 2 x 10\^6 /kg * Eastern Cooperative Oncology Group 0 - 2 * The MM patients who received induction chemotherapy regardless of types of induction * Patient has measurable disease when the patients started the primary induction therapy, defined as follows: Measurable disease is defined as serum M-protein more than 1 g/dL, urine M-protein more than 200 mg/24 hours, or free light chain more than 100 mg/L * Adequate liver functions before ASCT Transaminase less than 3 x upper normal value Bilirubin less than 2 x upper normal value * Adequate hematological function - Platelet count more than 50,000 /microliter, hemoglobin more than 8 g / dL but, Prior red blood cell transfusion or recombinant human erythropoietin use is allowed, absolute neutrophil count more than 1,000 / microliter * Expected survival: 6 months or more * Informed consent Exclusion Criteria: * Systemic amyloid light chain amyloidosis, smoldering multiple myeloma or monoclonal gammopathy of undetermined significance * Patient with plasma cell leukemia * Patients who received an extensive radiation therapy within 4 weeks * Patient is known to be Human Immunodeficiency Virus positive * Patient has known clinically active Hepatitis B or C * Pregnant or lactating women, women of childbearing potential not employing adequate contraception * Other serious illness or medical conditions Uncontrolled or severe cardiovascular disease, including myocardial infarction, within 6 months of enrollment, New York Heart Association Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis History of significant neurological or psychiatric disorders including dementia or seizures Active uncontrolled infection Active ulcers detected at gastroscopy Other serious medical illnesses * Known hypersensitivity to any of the study drugs or its ingredients concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
References
Publications (32)
- BACKGROUNDMcElwain TJ, Powles RL. High-dose intravenous melphalan for plasma-cell leukaemia and myeloma. Lancet. 1983 Oct 8;2(8354):822-4. doi: 10.1016/s0140-6736(83)90739-0. PMID 6137651
- BACKGROUNDSelby PJ, McElwain TJ, Nandi AC, Perren TJ, Powles RL, Tillyer CR, Osborne RJ, Slevin ML, Malpas JS. Multiple myeloma treated with high dose intravenous melphalan. Br J Haematol. 1987 May;66(1):55-62. doi: 10.1111/j.1365-2141.1987.tb06890.x. PMID 3593657
- BACKGROUNDBarlogie B, Tricot G, Anaissie E, Shaughnessy J, Rasmussen E, van Rhee F, Fassas A, Zangari M, Hollmig K, Pineda-Roman M, Lee C, Talamo G, Thertulien R, Kiwan E, Krishna S, Fox M, Crowley J. Thalidomide and hematopoietic-cell transplantation for multiple myeloma. N Engl J Med. 2006 Mar 9;354(10):1021-30. doi: 10.1056/NEJMoa053583. PMID 16525139
- BACKGROUNDAttal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204. PMID 8649495
- BACKGROUNDFermand JP, Ravaud P, Chevret S, Divine M, Leblond V, Belanger C, Macro M, Pertuiset E, Dreyfus F, Mariette X, Boccacio C, Brouet JC. High-dose therapy and autologous peripheral blood stem cell transplantation in multiple myeloma: up-front or rescue treatment? Results of a multicenter sequential randomized clinical trial. Blood. 1998 Nov 1;92(9):3131-6. PMID 9787148
- BACKGROUNDChild JA, Morgan GJ, Davies FE, Owen RG, Bell SE, Hawkins K, Brown J, Drayson MT, Selby PJ; Medical Research Council Adult Leukaemia Working Party. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med. 2003 May 8;348(19):1875-83. doi: 10.1056/NEJMoa022340. PMID 12736280