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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.
Many patients with multiple myeloma receive 2 stem cell transplantations within a few months of each other as part of their treatment. Usually the drug Melphalan is used for both transplants.
Bortezomib is a drug that is used for treating multiple myeloma and has been used in combination with melphalan for stem cell transplantation for patients with multiple myeloma.
The purpose of this trial is to study the effects of doing 2 transplants, first using melphalan and second using melphalan and bortezomib. The trial is aiming to find out if adding the Bortezomib to the second transplant will increase the chances of staying in remission longer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tandem Transplantation with Melphalan and Bortezomib | Experimental | Tandem autologous hematopoietic stem cell transplantation with melphalan followed by melphalan and bortezomib in patients with multiple myeloma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Bortezomib 1.6mg/m2 on day -4 and day -1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Progression-free survival of participants that received tandem transplants on study | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Changed from: Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michele Donato, MD | John Theurer Cancer Center at Hackensack University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Theurer Cancer Center @ Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10363983 | Background | Adams J, Palombella VJ, Sausville EA, Johnson J, Destree A, Lazarus DD, Maas J, Pien CS, Prakash S, Elliott PJ. Proteasome inhibitors: a novel class of potent and effective antitumor agents. Cancer Res. 1999 Jun 1;59(11):2615-22. | |
| 16135465 | Background | Aghajanian C, Dizon DS, Sabbatini P, Raizer JJ, Dupont J, Spriggs DR. Phase I trial of bortezomib and carboplatin in recurrent ovarian or primary peritoneal cancer. J Clin Oncol. 2005 Sep 1;23(25):5943-9. doi: 10.1200/JCO.2005.16.006. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tandem Transplantation With Melphalan and Bortezomib | Tandem autologous hematopoietic stem cell transplantation with melphalan followed by melphalan and bortezomib in patients with multiple myeloma Bortezomib: Bortezomib 1.6mg/m2 on day -4 and day -1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tandem Transplantation With Melphalan and Bortezomib | Tandem autologous hematopoietic stem cell transplantation with melphalan followed by melphalan and bortezomib in patients with multiple myeloma Bortezomib: Bortezomib 1.6mg/m2 on day -4 and day -1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Progression-free survival of participants that received tandem transplants on study | Posted | Number | 95% Confidence Interval | Percent | 3 years |
|
|
All-Cause Mortality was assessed for up to 3 years. Serious Adverse Events were assessed up to 100 days after bone marrow transplant
SAEs are reported through 100 days after bone marrow transplant. Other (Not Including Serious) Adverse Events were not analyzed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tandem Transplantation With Melphalan and Bortezomib | Tandem autologous hematopoietic stem cell transplantation with melphalan followed by melphalan and bortezomib in patients with multiple myeloma Bortezomib: Bortezomib 1.6mg/m2 on day -4 and day -1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Zenreich | Hackensack Meridian Health | 5519964248 | joshua.zenreich@hmhn.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2019 | Aug 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| 3 years |
| 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. | Survival rate of participants after completion of tandem transplant | 3 years |
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| Background | Rowley SD, Siegel, D, Donato ML,et al. Combination melphalan and bortezomib conditioning with autologous hematopoeitic stem cell support in patients with advanced multiple myeloma. A phase I/II study. Blood 2009;114:499 |
| 7602368 | Background | Samuels BL, Bitran JD. High-dose intravenous melphalan: a review. J Clin Oncol. 1995 Jul;13(7):1786-99. doi: 10.1200/JCO.1995.13.7.1786. |
| 9864145 | Background | Siegel DS, Desikan KR, Mehta J, Singhal S, Fassas A, Munshi N, Anaissie E, Naucke S, Ayers D, Spoon D, Vesole D, Tricot G, Barlogie B. Age is not a prognostic variable with autotransplants for multiple myeloma. Blood. 1999 Jan 1;93(1):51-4. |
| 12070031 | Background | Spanswick VJ, Craddock C, Sekhar M, Mahendra P, Shankaranarayana P, Hughes RG, Hochhauser D, Hartley JA. Repair of DNA interstrand crosslinks as a mechanism of clinical resistance to melphalan in multiple myeloma. Blood. 2002 Jul 1;100(1):224-9. doi: 10.1182/blood.v100.1.224. |
| 10499643 | Background | Teicher BA, Ara G, Herbst R, Palombella VJ, Adams J. The proteasome inhibitor PS-341 in cancer therapy. Clin Cancer Res. 1999 Sep;5(9):2638-45. |
| 7581132 | Background | Tricot G, Jagannath S, Vesole DH, Crowley J, Barlogie B. Relapse of multiple myeloma after autologous transplantation: survival after salvage therapy. Bone Marrow Transplant. 1995 Jul;16(1):7-11. |
| 9816255 | Background | Tricot G, Alberts DS, Johnson C, Roe DJ, Dorr RT, Bracy D, Vesole DH, Jagannath S, Meyers R, Barlogie B. Safety of autotransplants with high-dose melphalan in renal failure: a pharmacokinetic and toxicity study. Clin Cancer Res. 1996 Jun;2(6):947-52. |
| 11841419 | Background | Tricot G, Spencer T, Sawyer J, Spoon D, Desikan R, Fassas A, Badros A, Zangari M, Munshi N, Anaissie E, Toor A, Barlogie B. Predicting long-term (> or = 5 years) event-free survival in multiple myeloma patients following planned tandem autotransplants. Br J Haematol. 2002 Jan;116(1):211-7. doi: 10.1046/j.1365-2141.2002.03231.x. |
| 7913845 | Background | Vesole DH, Barlogie B, Jagannath S, Cheson B, Tricot G, Alexanian R, Crowley J. High-dose therapy for refractory multiple myeloma: improved prognosis with better supportive care and double transplants. Blood. 1994 Aug 1;84(3):950-6. |
| Lost to Follow-up |
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| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | 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. | 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. | 94 participant response assessed after completion of tandem transplant | Posted | Count of Participants | Participants | 3 years |
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| Secondary | 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. | Survival rate of participants after completion of tandem transplant | 94 participant survival assessed after completion of tandem transplant | Posted | Count of Participants | Participants | 3 years |
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| 46 |
| 142 |
| 67 |
| 142 |
| 0 |
| 0 |
| Infection | Infections and infestations | Systematic Assessment |
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| Disease Progression | Investigations | Systematic Assessment |
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| Fever | Investigations | Systematic Assessment |
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| Engraftment Syndrome | Immune system disorders | Systematic Assessment |
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| Failure to Thrive | Investigations | Systematic Assessment |
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| RSV | Infections and infestations | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Perrirectal Abcess | Infections and infestations | Systematic Assessment |
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| Subdermal Hematoma | Vascular disorders | Systematic Assessment |
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| Acute Renal Insufficiency | Renal and urinary disorders | Systematic Assessment |
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| Tumor Lysis Syndrome | Metabolism and nutrition disorders | Systematic Assessment |
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| Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| CMV Viremia | Infections and infestations | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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Not provided
Not provided
Not provided
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |