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Multiple MyelomaPhase 2NCT00001750

Comparing Treatments for Multiple Myeloma

A Phase 2 study testing Stemgen in people with Multiple Myeloma, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Multiple Myeloma
What is being tested?
Stemgen
How many people
32 participants
Where
1 siteUnited States
Study dates
Sep 1998to Aug 2002
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Heart, Lung and Blood Institute (NHLBI)

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: 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.

Read the detailed description

Some drugs, such as hematopoietic cytokines, result in mobilization of primitive stem cells out of the bone marrow space and into the blood, but the mechanisms of this process are still poorly understood. A better understanding of this process could greatly improve clinical results in transplantation, cancer treatment, and potentially genetic therapy of a wide variety of disorders. In this protocol, we will study two different mobilization treatments and compare how efficient they are at increasing the number of primitive cells in the blood in patients with multiple myeloma. These cells will be collected by apheresis, and used for autologous transplantation following high dose chemotherapy. This aggressive approach to treatment in multiple myeloma has been shown to improve remission rates and survival without active disease. The use of a larger number of blood stem cells may decrease the toxicity associated with the procedure. In the research laboratory, we will study a number of characteristics of the primitive cells in the blood and the bone marrow after treatment with the mobilizing drugs. These studies will help us to design future transplantation and genetic therapy protocols.

Being tested
Stemgen
Keywords
G-CSF, Cell-Cycle, Stem Cell, Apheresis, Melphalan, Gene Transfer, Retroviral Receptor, Stem Cell Expansion, Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StemgenDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 1999 (estimated)
  2. Study startSep 1998
  3. Study completionAug 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
32 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001750
Sponsor's protocol ID
980154
Other IDs
98-H-0154
Status last verified
Aug 2002
First submitted
3 Nov 1999
Last updated
4 Mar 2008
Results posted
No

Publications

  • 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.

    PubMed 8704239

  • 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.

    PubMed 7538814

  • 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.

    PubMed 7533017

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stemgen in people with Multiple Myeloma, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001750, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.

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Comparing Treatments for Multiple Myeloma | AzTrials