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Donor Stem Cell Transplant As Consolidation Therapy May Be Effective And Safe In Myeloma
By: Virginia Li; Published: May 11, 2013 @ 9:42 am | Comments Disabled
The results of a small, retrospective study indicate that donor stem cell transplantation may be effective and well tolerated in multiple myeloma patients who have a deep response to initial therapy.
Specifically, the researchers found that for the majority of patients, stem cell transplantation deepened their initial response to a complete or stringent complete response.
Two years following transplantation, three-quarters of the patients were disease-free, which according to the researchers shows that donor transplantation may be a good tool for the prevention of early relapse and progression of the disease.
However, the study investigators point out that a larger number of patients will be needed to evaluate the efficacy of donor transplantation as consolidation therapy (following initial therapy). A Phase 2 study is currently underway to follow up on these findings.
Background
Autologous stem cell transplantation is frequently used as early treatment in myeloma patients up to 65 years of age. In this process, the patient’s own stem cells are collected before receiving high-dose chemotherapy, which destroys the cancerous cells as well as the patient’s healthy bone marrow cells. The stem cells are then returned to the patient following chemotherapy, and the stem cells eventually mature to replace the destroyed cells.
The role of donor (allogeneic) stem cell transplantation in multiple myeloma, however, is still controversial. In this procedure, the patient receives stem cells from a matched donor instead of from his or her own body.
Although donor transplantation gives myeloma patients a better chance for a cure than autologous transplantation, it also carries a greater risk of life-threatening diseases such as graft-versus-host disease (GVHD), a condition in which immune cells from the donor attack the recipient’s cells.
Because of these risks, donor stem cell transplants are mostly done in the context of clinical trials.
Consolidation therapy is a short course of treatment meant to deepen a patient's response to prior treatments. It is different from maintenance therapy, which typically involves a longer regimen meant to prevent disease progression while maintaining a favorable quality of life.
According to the investigators of the current study, the use of donor stem cell transplantation as consolidation therapy has not been well studied.
They therefore sought to investigate the efficacy of donor transplantation as consolidation therapy in patients who had reached a very good partial response or a complete response after initial therapy.
Study Design
Researchers from the Lee Moffitt Cancer Center in Tampa, Florida, retrospectively analyzed data from 22 multiple myeloma patients who, between 2007 and 2012, had achieved a very good partial response or a complete response after initial therapy with Velcade [1] (bortezomib) or Revlimid [2] (lenalidomide) and went on to receive a donor transplant as consolidation therapy. The median patient age was 49 years.
Patients had received either Velcade plus fludarabine (Fludara) and melphalan [1] (Alkeran) or fludarabine and melphalan alone as a reduced-intensity conditioning regimen prior to donor transplantation.
Patients in the Velcade-conditioning group received 30 mg/m2 of fludarabine for four straight days up until the third day before transplantation, 70 mg/m2 of melphalan for two days up until the third day before transplantation, and 1.3 mg/m2 of Velcade immediately after the last dose of melphalan.
Patients who did not receive Velcade as part of their conditioning regimen received 40 mg/m2 of fludarabine for four days up until the third day before transplantation and 70 mg/m2 of melphalan for two days until the third day before transplantation.
The researchers also retrospectively identified 41 myeloma patients with similar characteristics who received an autologous transplant to serve as a comparison group. These patients had a median age of 54 years and had reached their first very good partial response or complete response just prior to transplantation.
Study Results
Prior to receiving a donor transplant, 27 percent of patients achieved a stringent complete response. This measure increased to 68 percent after donor transplantation.
Of the patients who had reached a very good partial response prior to donor transplantation, 33 percent improved their response to a complete response and 42 percent improved to a stringent complete response following donor transplantation.
Among the patients who underwent autologous transplantation, 21 percent of patients reached a complete response and 57 percent reached a stringent complete response after transplantation.
Two years post-transplant, 8 percent of patients in the donor transplant group relapsed, compared to 46 percent in the autologous transplant group.
The estimated two-year progression-free survival rate for patients who underwent donor transplantation was 75 percent, compared to 52 percent for patients who underwent autologous transplantation.
The estimated two-year overall survival rate for the donor transplant group was 78 percent, versus 90 percent for the autologous transplant group.
Graft-versus-host disease (GVHD) was a common side effect among patients undergoing donor transplantation.
Overall, 45 percent of patients experienced moderate to severe acute GVHD, which occurs within 100 days of transplantation. Furthermore, 46 percent of patients experienced chronic GVHD, which occurs 100 or more days after transplantation.
After donor transplantation, 18 percent of patients died of GVHD-related complications and 5 percent died from disease progression.
For more information, please see the study in the journal Bone Marrow Transplantation [3] (abstract).
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URL to article: https://myelomabeacon.org/news/2013/05/11/donor-stem-cell-transplant-consolidation-therapy-multiple-myeloma/
URLs in this post:
[1] Velcade: https://myelomabeacon.org/resources/2008/10/15/velcade/
[2] Revlimid: https://myelomabeacon.org/resources/2008/10/15/revlimid/
[3] Bone Marrow Transplantation: http://www.nature.com/bmt/journal/vaop/ncurrent/full/bmt201337a.html
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