Auto-Allo Tandem Stem Cell Transplantation for Patients With Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT00777998 |
Recruitment Status : Unknown
Verified May 2018 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was: Active, not recruiting
First Posted : October 23, 2008
Last Update Posted : May 4, 2018
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Condition or disease | Intervention/treatment | Phase |
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Multiple Myeloma | Procedure: Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI Procedure: auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 221 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Autologous-Allogeneic Tandem Stem Cell Transplantation and Maintenance Therapy With Thalidomide/ DLI for Patients With Multiple Myeloma (MM) and Age < _60 Years: A Phase II-study |
Actual Study Start Date : | October 14, 2008 |
Actual Primary Completion Date : | April 17, 2018 |
Estimated Study Completion Date : | June 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Auto-Allo Tandem Stem cell Transplantation plus maintenance therapy with Thalidomide and DLI
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Procedure: Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI
*Multiple myeloma
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Active Comparator: B
Auto-Auto Tandem stem cell Transplantation plus maintenance therapy with Thalidomide
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Procedure: auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide
*Multiple myeloma
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- Event-free survival 4 years after auto-allo/ auto-auto Tandem-SCT. Any of the following will be considered an endpoint event: recurrence or progression of primary disease, disease related mortality, or treatment related mortality. [ Time Frame: four years after Tandem stem cell transplantation ]
- Incidence of acute GvHD [ Time Frame: day +100 after allogeneic stem cell transplantation ]
- Incidence of chronic GvHD [ Time Frame: at one year and at two years after allogeneic stem cell transplantation ]
- Toxicity of conditioning regimen and of maintenance therapy [ Time Frame: Throughout conditioning regimen and maintenance therapy ]
- cumulative incidence of relapse [ Time Frame: four years after Tandem stem cell transplantation ]
- Disease related mortality [ Time Frame: four years after allogeneic stem cell transplantation ]
- Treatment related mortality [ Time Frame: four years after allogeneic stem cell transplantation ]
- overall survival [ Time Frame: four years after allogeneic stem cell transplantation ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Multiple Myeloma Stage II or III acc. to Salmon and Durie
- Patient's age 18-60 years
- Patient's written informed consent
- Women and men capable of reproduction must agree to use adequate contraceptive measures (condom, IUD, oral contraceptives) until three months after termination of treatment
- a maximum of eight chemotherapy cycles prior to registration (CR/ PR/ MR/ or PD)
Exclusion Criteria:
- More than eight chemotherapy cycles prior to registration
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severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
- total bilirubin, SGPT or SGOT > 3 times upper the normal level
- Left ventricular ejection fraction < 30 %
- Creatinine Clearance < 30 ml/min
- DLCO < 35 % and/or receiving supplementary continuous oxygen
- Positive serology for HIV
- Pregnant or lactating women
- Participation in another trial at the time of registration
- Preceding autologous stem cell transplantation
- age > 61 years

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777998

Principal Investigator: | Nicolaus Kroeger, Prof. Dr. | University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation |
Responsible Party: | Universitätsklinikum Hamburg-Eppendorf |
ClinicalTrials.gov Identifier: | NCT00777998 |
Other Study ID Numbers: |
Auto-Allo TSCT in MM |
First Posted: | October 23, 2008 Key Record Dates |
Last Update Posted: | May 4, 2018 |
Last Verified: | May 2018 |
Multiple Myeloma Stem Cell Transplantation Thalidomide DLI |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Ferrous fumarate |
Thalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Trace Elements Micronutrients Nutrients |