- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01923935
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
Study Overview
Detailed Description
Title
- 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 (MM) undergoing autologous stem cell transplantation (ASCT)
Principal Investigator
- Je-Jung Lee (Chonnam National University Hwasun Hospital)
Co-investigators
- Hyeon Seok Eom (National Cancer Center)
- Kihyun Kim (Samsung Medical Center)
- Chang Ki Min (Seoul St. Mary's Hospital)
- Soo Jung Kim (Severance Hospital)
- Sung Soo Yoon (Seoul National University Hospital)
- Jae Hoon Lee (Gachon University Gil Hospital)
- Yeung-Chul Mun (Ewha Womans University Mokdong Hospital)
Duration
- 2 years
Study phase
- Phase II
Patients
- Patients with multiple myeloma who undergo autologous stem cell transplantation
Objectives(end points)
Primary objective:
- Treatment response up to 2 months after ASCT
- Safety and toxicity (frequency of grade 3 or worse toxicities) of the conditioning regimen
Secondary objective:
- Progression free survival (PFS)
- Overall survival (OS)
Total patients
- Initial 105 evaluable patients
- Complete Response (CR) rate of 200mg/m2 melphalan conditioning chemotherapy followed by ASCT in patients with newly diagnosed MM was about 26% and CR rate of busulfan and melphalan conditioning chemotherapy followed by ASCT in patients with newly diagnosed MM was about 40%. If the CR rate of busulfan and melphalan conditioning chemotherapy followed by ASCT is more than 40%, this combination will be accepted as active conditioning regimen that may be worth for investigating in phase III trial. But, if the CR rate of this regimen is lower than 26%, this has not a merit than 200mg/m2 melphalan conditioning chemotherapy. Based upon the above assumption, this trial was designed by using Simon's optimal two-stage testing procedure. Assuming a target level of interest, p1=0.4, and a lower activity level, p0=0.26 and drop rate 0.1. Initially 44 patients will be accrued. If 13 or more CR rate were observed, the trial will be continued. Accrual will be planned to a total of 105 patients, If total 35 or more patients were assessed as CR, busulfan and melphalan conditioning regimen will be accepted as active regimen, This design provides probability ≤ 0.05 of accepting drugs worse than p0 and probability ≤ 0.20 of rejecting drugs better than p1.if we assume that drop-out rate is 10%, total accrual patient will be 105
Treatment Schedule
- Busulfan 3.2 mg/kg/day iv once daily over 3 hours(day-6 ~ day-4)
- Melphalan 70 mg/m2/day iv once daily over 30 minutes(day-3 ~ day-1). If Creatinine Clearance (mL/min) < 50, reduce to 50 mg/m2. If Creatinine Clearance (mL/min) < 30, excluded from the this trial
Informed consent
- Written informed consent must be obtained before any study-specific screening procedures are performed
Screening
Baseline assessments should be made within 28 days before treatment start:
- Demographic data (date of birth and sex)
- Eastern Cooperative Oncology Group performance status
- Vital signs and physical examination (including height, and weight)
- Medical history (including previous diseases/treatments and concomitant diseases/ treatments)
- Hematology - complete blood counts with differential count examination
- Serum electrolytes (Na, K, Cl, Ca, phosphorus)
- Serum lactate dehydrogenase
- Hepatitis B virus/hepatitis C virus/HIV serology (If serologic tests were conducted within 6 months prior to screening, retests are not required)
- Serum Beta2-microglobulin
- Quantitative serum M-protein (Serum protein electrophoresis), including immunofixation or immune electrophoresis
- Quantitative urine M-protein in 24 hrs urine (Urine protein electrophoresis), including immunofixation or immune electrophoresis
- Serum free light chain assay
- Creatinine clearance if increased serum creatinine
- ECG
- multigated radionuclide angiography or 2D ECHO
- Chest X-ray, Radiographic skeletal survey including skull, pelvis, vertebral column and long bones
- Bone marrow aspiration and biopsy with chromosome study, and flow cytometry or immunohistochemistry
Assessment
Primary outcome measure
- To evaluate the objective responses after ASCT, the guidelines from the International Myeloma Working (IMW) Group uniform response criteria 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)
- Serum free light chain study will be added at the every evaluation of response
- To confirm the stringent complete response (sCR) after ASCT, flow cytometry or immunohistochemistry will be used
- NCI Common Toxicity Criteria for Adverse Effects version 4.0 will be used for the examination of toxicities
Secondary outcome measure
- PFS will be defined from the time of ASCT to the time of first sign of disease progression or death
- OS will be defined as the period from the time of ASCT to the date of the last follow-up or death from any cause
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Je-Jung Lee, M.D., PH.D.
- Phone Number: 82-61-379-7638
- Email: f0115@chonnam.ac.kr
Study Contact Backup
- Name: Deok-Hwan Yang, M.D., PH.D.
- Phone Number: 82-61-379-7636
- Email: drydh@chonnam.ac.kr
Study Locations
-
-
Gyeonggi
-
Goyang-si, Gyeonggi, Korea, Republic of, 410-769
- Recruiting
- National Cancer Center
-
Contact:
- Hyeon Seok Eom, M.D., Ph.D.
- Phone Number: 82-31-920-2402
- Email: hseom@ncc.re.kr
-
Principal Investigator:
- Hyeon Seok Eom, M.D., Ph.D.
-
-
Incheon
-
Namdong-gu, Incheon, Korea, Republic of, 405-760
- Not yet recruiting
- Gachon University Gil Hospital
-
Contact:
- Jae Hoon Lee, M.D., Ph.D.
- Phone Number: 82-32-460-2186
- Email: jhlee@gilhospital.com
-
Principal Investigator:
- Jae Hoon Lee, M.D., Ph.D.
-
-
Jeollanam-do
-
Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-763
- Recruiting
- Chonnam National University Hwasun Hospital
-
Contact:
- Je-Jung Lee, M.D, Ph.D.
- Phone Number: 82-61-379-7638
- Email: f0115@chonnam.ac.kr
-
Contact:
- Jae-Sook Ahn, M.D, Ph.D.
- Phone Number: 82-61-379-7635
- Email: ahnjaesook@hanmail.net
-
Principal Investigator:
- Je-Jung Lee, M.D., Ph.D.
-
Sub-Investigator:
- Deok-Hwan Yang, M.D., Ph.D.
-
Sub-Investigator:
- Jae-Sook Ahn, M.D., Ph.D.
-
Sub-Investigator:
- Sung-Hoon Jung, M.D.
-
-
Seoul
-
Gangnam-gu, Seoul, Korea, Republic of, 135-710
- Not yet recruiting
- Samsung Medical Center
-
Contact:
- Kihyun Kim, M.D., Ph.D.
- Phone Number: 82-2-3410-3459
- Email: kihyunk@skku.edu
-
Principal Investigator:
- Kihyun Kim, M.D., Ph.D.
-
Jongno-gu, Seoul, Korea, Republic of, 110-744
- Not yet recruiting
- Seoul National University Hospital
-
Contact:
- Sung Soo Yoon, M.D., Ph.D.
- Phone Number: 82-2-2072-3079
- Email: ssysmc@snu.ac.kr
-
Principal Investigator:
- Sung Soo Yoon, M.D., Ph.D.
-
Mokdong, Seoul, Korea, Republic of, 158-710
- Not yet recruiting
- Ewha Womans University Mokdong Hospital
-
Contact:
- Yeung-Chul Mun, M.D., Ph.D.
- Phone Number: 82-2-2650-2777
- Email: yeungchul@ewha.ac.kr
-
Principal Investigator:
- Yeung-Chul Mun, M.D., Ph.D.
-
Seocho-gu, Seoul, Korea, Republic of, 137-701
- Not yet recruiting
- Seoul St. Mary's Hospital
-
Contact:
- Chang Ki Min, M.D., Ph.D.
- Phone Number: 82-2-2258-6053
- Email: ckmin@catholic.ac.kr
-
Principal Investigator:
- Chang Ki Min, M.D., Ph.D.
-
Seodaemun-gu, Seoul, Korea, Republic of, 120-752
- Not yet recruiting
- Severance Hospital
-
Contact:
- Soo Jung Kim, M.D.
- Phone Number: 82-2-2228-5487
- Email: ALVIN97@yuhs.ac
-
Principal Investigator:
- Soo Jung Kim, M.D., Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BUSULFEX®, Alkeran®
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) |
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment response up to 2 months after ASCT
Time Frame: 2 months later after last patent received ASCT
|
Response Criteria for Multiple Myeloma: the guidelines from the IMW Group uniform response criteria + Add for criteria of near CR (Immunofixation positive CR) |
2 months later after last patent received ASCT
|
Safety and toxicity (frequency of grade 3 or worse toxicities) of the conditioning regimen
Time Frame: 2 months later after last patent received ASCT
|
NCI Common Toxicity Criteria for Adverse Effects version 4.0 will be used for the examination of toxicities.
|
2 months later after last patent received ASCT
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival(PFS)
Time Frame: 2 months later after last patient received ASCT
|
PFS will be defined from the time of ASCT to the time of first sign of disease progression or death.
|
2 months later after last patient received ASCT
|
Overall survival (OS)
Time Frame: 2 months later after last patient received ASCT
|
OS will be defined as the period from the time of ASCT to the date of the last follow-up or death from any cause.
|
2 months later after last patient received ASCT
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Je-Jung Lee, M.D., Ph.D., Chonnam National University Hospital
Publications and helpful links
General Publications
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- Sirohi B, Powles R, Mehta J, Raje N, Kulkarni S, Ramiah V, Saso R, Horton C, Bhagwati N, Singhal S, Treleaven J. Complete remission rate and outcome after intensive treatment of 177 patients under 75 years of age with IgG myeloma defining a circumscribed disease entity with a new staging system. Br J Haematol. 1999 Dec;107(3):656-66. doi: 10.1046/j.1365-2141.1999.01744.x.
- Goldschmidt H, Hegenbart U, Wallmeier M, Hohaus S, Haas R. Factors influencing collection of peripheral blood progenitor cells following high-dose cyclophosphamide and granulocyte colony-stimulating factor in patients with multiple myeloma. Br J Haematol. 1997 Sep;98(3):736-44. doi: 10.1046/j.1365-2141.1997.2783095.x.
- Barlogie B, Alexanian R, Dicke KA, Zagars G, Spitzer G, Jagannath S, Horwitz L. High-dose chemoradiotherapy and autologous bone marrow transplantation for resistant multiple myeloma. Blood. 1987 Sep;70(3):869-72.
- Jagannath S, Vesole DH, Glenn L, Crowley J, Barlogie B. Low-risk intensive therapy for multiple myeloma with combined autologous bone marrow and blood stem cell support. Blood. 1992 Oct 1;80(7):1666-72.
- Garban F, Attal M, Michallet M, Hulin C, Bourhis JH, Yakoub-Agha I, Lamy T, Marit G, Maloisel F, Berthou C, Dib M, Caillot D, Deprijck B, Ketterer N, Harousseau JL, Sotto JJ, Moreau P. Prospective comparison of autologous stem cell transplantation followed by dose-reduced allograft (IFM99-03 trial) with tandem autologous stem cell transplantation (IFM99-04 trial) in high-risk de novo multiple myeloma. Blood. 2006 May 1;107(9):3474-80. doi: 10.1182/blood-2005-09-3869. Epub 2006 Jan 5.
- Moreau P, Milpied N, Mahe B, Juge-Morineau N, Rapp MJ, Bataille R, Harousseau JL. Melphalan 220 mg/m2 followed by peripheral blood stem cell transplantation in 27 patients with advanced multiple myeloma. Bone Marrow Transplant. 1999 May;23(10):1003-6. doi: 10.1038/sj.bmt.1701763.
- Mansi J, da Costa F, Viner C, Judson I, Gore M, Cunningham D. High-dose busulfan in patients with myeloma. J Clin Oncol. 1992 Oct;10(10):1569-73. doi: 10.1200/JCO.1992.10.10.1569.
- Bensinger WI, Rowley SD, Demirer T, Lilleby K, Schiffman K, Clift RA, Appelbaum FR, Fefer A, Barnett T, Storb R, Chauncey T, Maziarz RT, Klarnet J, McSweeney P, Holmberg L, Maloney DG, Weaver CH, Buckner CD. High-dose therapy followed by autologous hematopoietic stem-cell infusion for patients with multiple myeloma. J Clin Oncol. 1996 May;14(5):1447-56. doi: 10.1200/JCO.1996.14.5.1447.
- Alegre A, Lamana M, Arranz R, Fernandez-Villalta MJ, Tomas JF, Figuera A, Camara R, Steegman JL, Casado F, Requena MJ, et al. Busulfan and melphalan as conditioning regimen for autologous peripheral blood stem cell transplantation in multiple myeloma. Br J Haematol. 1995 Oct;91(2):380-6. doi: 10.1111/j.1365-2141.1995.tb05307.x.
- Fermand JP, Chevret S, Ravaud P, Divine M, Leblond V, Dreyfus F, Mariette X, Brouet JC. High-dose chemoradiotherapy and autologous blood stem cell transplantation in multiple myeloma: results of a phase II trial involving 63 patients. Blood. 1993 Oct 1;82(7):2005-9.
- Ventura GJ, Barlogie B, Hester JP, Yau JC, LeMaistre CF, Wallerstein RO, Spinolo JA, Dicke KA, Horwitz LH, Alexanian R. High dose cyclophosphamide, BCNU and VP-16 with autologous blood stem cell support for refractory multiple myeloma. Bone Marrow Transplant. 1990 Apr;5(4):265-8.
- Roussel M, Moreau P, Huynh A, Mary JY, Danho C, Caillot D, Hulin C, Fruchart C, Marit G, Pegourie B, Lenain P, Araujo C, Kolb B, Randriamalala E, Royer B, Stoppa AM, Dib M, Dorvaux V, Garderet L, Mathiot C, Avet-Loiseau H, Harousseau JL, Attal M; Intergroupe Francophone du Myelome (IFM). Bortezomib and high-dose melphalan as conditioning regimen before autologous stem cell transplantation in patients with de novo multiple myeloma: a phase 2 study of the Intergroupe Francophone du Myelome (IFM). Blood. 2010 Jan 7;115(1):32-7. doi: 10.1182/blood-2009-06-229658. Epub 2009 Nov 2.
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- Carreras E, Rosinol L, Terol MJ, Alegre A, de Arriba F, Garcia-Larana J, Bello JL, Garcia R, Leon A, Martinez R, Penarrubia MJ, Poderos C, Ribas P, Ribera JM, San Miguel J, Blade J, Lahuerta JJ; Spanish Myeloma Group/PETHEMA. Veno-occlusive disease of the liver after high-dose cytoreductive therapy with busulfan and melphalan for autologous blood stem cell transplantation in multiple myeloma patients. Biol Blood Marrow Transplant. 2007 Dec;13(12):1448-54. doi: 10.1016/j.bbmt.2007.08.002.
- Lahuerta JJ, Mateos MV, Martinez-Lopez J, Grande C, de la Rubia J, Rosinol L, Sureda A, Garcia-Larana J, Diaz-Mediavilla J, Hernandez-Garcia MT, Carrera D, Besalduch J, de Arriba F, Oriol A, Escoda L, Garcia-Frade J, Rivas-Gonzalez C, Alegre A, Blade J, San Miguel JF; Grupo Espanol de MM and Programa para el Estudio de la Terapeutica en Hemopatia Maligna Cooperative Study Groups. Busulfan 12 mg/kg plus melphalan 140 mg/m2 versus melphalan 200 mg/m2 as conditioning regimens for autologous transplantation in newly diagnosed multiple myeloma patients included in the PETHEMA/GEM2000 study. Haematologica. 2010 Nov;95(11):1913-20. doi: 10.3324/haematol.2010.028027. Epub 2010 Jul 27.
- Jung SH, Lee JJ, Kim JS, Min CK, Kim K, Choi Y, Eom HS, Joo YD, Kim SH, Kwak JY, Kang HJ, Lee JH, Lee HS, Mun YC, Moon JH, Sohn SK, Park SK, Park Y, Shin HJ, Yoon SS; Korean Multiple Myeloma Working Party. Phase 2 Study of an Intravenous Busulfan and Melphalan Conditioning Regimen for Autologous Stem Cell Transplantation in Patients with Multiple Myeloma (KMM150). Biol Blood Marrow Transplant. 2018 May;24(5):923-929. doi: 10.1016/j.bbmt.2018.01.004. Epub 2018 Jan 12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Melphalan
- Busulfan
Other Study ID Numbers
- KFDA20120110139
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Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
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National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on BUSULFEX®
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Marina KremyanskayaIncyte CorporationWithdrawnMyelofibrosis | MF
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Guido TricotOtsuka Pharmaceutical Development & Commercialization, Inc.TerminatedMultiple Myeloma
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Ann & Robert H Lurie Children's Hospital of ChicagoWithdrawnRefractory Brain Tumors
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University of ArizonaCompletedHematologic Neoplasms | Multiple Myeloma | Myelofibrosis | Anemia, Aplastic | Hemoglobinuria, ParoxysmalUnited States
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St. Jude Children's Research HospitalNational Heart, Lung, and Blood Institute (NHLBI); Assisi Foundation; California...SuspendedSevere Combined Immunodeficiency Disease, X-linkedUnited States
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Otsuka Pharmaceutical Development & Commercialization...CompletedMultiple MyelomaUnited States, Canada
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Columbia UniversityTerminatedNeuroblastomaUnited States
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Memorial Sloan Kettering Cancer CenterPediatric Brain Tumor ConsortiumTerminatedFanconi Anemia | Myelodysplastic Syndrome (MDS) | Acute Myelogenous Leukemia (AML)United States
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M.D. Anderson Cancer CenterIncyte CorporationNot yet recruitingMyelofibrosis | SplenomegalyUnited States
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Medical College of WisconsinNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaboratorsCompleted