- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001750
Comparing Treatments for Multiple Myeloma
Randomized Trial of Autologous Transplantation With Filgrastim Versus Stem Cell Factor/Filgrastim-Primed CD34-Enriched Peripheral Blood Cells for Multiple Myeloma
Some drugs have the ability to push stem cells (the cells responsible for producing new cell types) out of the bone marrow and into the blood stream. The steps involved in this process are still poorly understood. However, a better understanding of this process could lead to improved results in transplantation, cancer treatment, and contribute to the development of new genetic therapies for a wide variety of disorders.
In this study researchers plan to compare two different treatments, both that mobilize (push) stem cells out of the bone marrow into the blood stream. In addition, researchers will attempt to determine which is the most efficient at mobilizing blood cells of patients with multiple myeloma.
Information and knowledge gained from this study will help to design future transplantation and genetic therapy research studies.
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Heart, Lung and Blood Institute (NHLBI)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA
Age 70 or younger at time of pretransplant evaluation.
An established diagnosis of multiple myeloma.
ECOG performance status of 0 or 1 and a life-expectancy of greater than 6 months.
Marrow cellularity greater than 20 percent, with less than or equal to 30 percent plasma cells within one month of study entry.
Platelet count greater than 100,000/ul, ANC greater than 1200/ul.
Demonstration of a partial or complete response to initial or salvage therapy (a minimum of a 50 percent reduction in the detectable serum paraprotein or at least a 90 percent reduction in the detectable urine monoclonal light chains, stable for at least four weeks prior to entry into study). A cumulative total of less than or equal to 6 cycles of regimens containing alkylating agents.
Bilirubin less than 2.0, transaminases less than 2x upper limit of normal, serum creatinine less than 3.0.
Ability and willingness to give informed consent.
EXCLUSION CRITERIA
Prior bone marrow or PBSC transplant.
HIV positivity.
Extensive marrow fibrosis, non-aspirable marrow, myelodysplastic changes or greater than 30 percent marrow plasma cells.
Prior treatment with greater than 6 cycles of chemotherapy regimens containing alkylating agents such as melphalan, cyclophosphamide or BCNU.
History of another malignancy within 5 years of protocol entry, with the exception of localized carcinomas cured by surgical resection such as basal cell carcinoma, stage I breast or bladder cancer, or in situ carcinoma of the cervix.
Significant nonmalignant disease including uncontrolled hypertension, unstable angina, congestive heart failure, poorly controlled diabetes, coronary angioplasty within 6 months, myocardial infarction within 6 months, uncontrolled arrhythmias, or any other medical condition felt by the principal investigator to unduly increase the risk of autologous transplantation.
Significant allergy history: these criteria will be assessed via the Allergy History CRF Screening Form.
Patients with any of the following concurrent conditions are not eligible:
No history of positive allergy tests to insect venoms (either skin or RAST).
No history of seasonal or recurrent asthma within the preceding 10 years.
No asthmatic symptoms (e.g. wheezing) related to a current respiratory tract infection.
No anaphylactic/anaphylactoid-type event manifested by disseminated urticaria, laryngeal edema, and/or bronchospasm (or for example: food, insect bites, etc.) Patients with drug allergies, manifest solely by rash, and/or urticaria are not excluded.
No history of angioedema or recurrent urticaria (an isolated episode of urticaria is not a contraindication).
No active infection (including those with current symptoms of bronchoconstriction), or fever greater than or equal to 38.2 degrees Celsius.
No known allergy to E. coli-derived products.
No concurrent use of beta adrenergic blocking agents.
No concurrent use of other investigative agents.
No pregnancy or breast-feeding. Men and women of child-bearing potential, admitted to the trial are to be advised to take adequate measures to prevent conception.
Patients maintained on interferon, chemotherapy or hematopoietic growth factors must have these treatments discontinued for at least four weeks prior to entry into this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Publications and helpful links
General Publications
- Dunbar CE, Cottler-Fox M, O'Shaughnessy JA, Doren S, Carter C, Berenson R, Brown S, Moen RC, Greenblatt J, Stewart FM, et al. Retrovirally marked CD34-enriched peripheral blood and bone marrow cells contribute to long-term engraftment after autologous transplantation. Blood. 1995 Jun 1;85(11):3048-57.
- Vesole DH, Tricot G, Jagannath S, Desikan KR, Siegel D, Bracy D, Miller L, Cheson B, Crowley J, Barlogie B. Autotransplants in multiple myeloma: what have we learned? Blood. 1996 Aug 1;88(3):838-47.
- McNiece IK, Briddell RA, Yan XQ, Hartley CA, Gringeri A, Foote MA, Andrews RG. The role of stem cell factor in mobilization of peripheral blood progenitor cells. Leuk Lymphoma. 1994 Nov;15(5-6):405-9. doi: 10.3109/10428199409049743.
Study record dates
Study Major Dates
Study Start
Study Completion
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
Keywords
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
Other Study ID Numbers
- 980154
- 98-H-0154
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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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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
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Barbara Ann Karmanos Cancer InstituteNational 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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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