High dose chemotherapy with stem cell transplantation is commonplace in the treatment of multiple myeloma. This treatment uses a chemotherapy drug called Melphalan that has been used in several thousand bone marrow transplant recipients worldwide for the same or similar disorders.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Tandem Transplantation with Melphalan and Bortezomib
description
Tandem autologous hematopoietic stem cell transplantation with melphalan followed by melphalan and bortezomib in patients with multiple myeloma
interventionNames
Drug: Bortezomib
Primary outcomes (1)
measure
To Determine the Progression-free Survival of Patients With Multiple Myeloma Treated With Tandem Cycles of High-dose Melphalan Followed by High-dose Melphalan in Combination With Bortezomib With Autologous HSC Transplantation.
timeFrame
3 years
description
Progression-free survival of participants that received tandem transplants on study
Secondary outcomes (2)
measure
To Determine the Response Rate of Patients With Multiple Myeloma Treated With High-dose Melphalan or High-dose Melphalan in Combination With Bortezomib Given in Tandem Transplants.
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Maximum age
75 Years
Show eligibility criteria text
Changed from: Inclusion Criteria:
* Confirmed diagnosis of multiple myeloma with either Durie-Salmon stage I, II, or III or ISS stage I, II or III, less than 12 months since initiation of systemic therapy
* ≥8x106 CD34+cells/kg available in cryopreservation in aliquots appropriate for tandem transplants
* Age: 18-75 years at time of transplantation
* KPS 70-100%
* Recovery from complications of prior therapies
* Gender: There is no gender restriction
Exclusion Criteria:
* Diagnosis other than multiple myeloma
* Chemotherapy or radiotherapy within 8 days of initiating treatment in this study
* Prior autologous or allogeneic transplantation (except as enrolled into this study)
* Uncontrolled bacterial, viral, fungal or parasitic infections
References
Publications (62)
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timeFrame
3 years
description
Overall response rate of participants after completing tandem transplant. Overall Response rate defined as the composite endpoint of response to treatment which includes Complete Response (CR), Partial Response (PR), stable disease (SD) as defined in International Response Criteria.
measure
To Determine the Overall Survival of Patients With Multiple Myeloma Treated With High-dose Melphalan or High-dose Melphalan in Combination With Bortezomib Given in Tandem Transplants.
timeFrame
3 years
description
Survival rate of participants after completion of tandem transplant
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