Comparing Treatments for Multiple Myeloma

NCT00001750 | Completed Phase 2

• 2 other identifiers: 98015498-H-0154
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma

Keywords

G-CSF; Cell-Cycle; Stem Cell; Apheresis; Melphalan; Gene Transfer; Retroviral Receptor; Stem Cell Expansion; Multiple Myeloma

Interventions

Stemgen DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 8704239 BACKGROUND

• 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.

  PMID: 7538814 BACKGROUND

• 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.

  PMID: 7533017 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ancestim

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: September 1, 1998
• Study Completion: August 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-08

Locations

US (1)