NEWS HIGHLIGHTS
Published Studies Related to Alkeran (Melphalan)
Efficacy of melphalan and prednisone plus thalidomide in patients older than 75 years with newly diagnosed multiple myeloma: IFM 01/01 trial. [2009.08.01]
PURPOSE: Until recently, melphalan and prednisone were the standards of care in elderly patients with multiple myeloma. The addition of thalidomide to this combination demonstrated a survival benefit for patients age 65 to 75 years. This randomized, placebo-controlled, phase III trial investigated the efficacy of melphalan and prednisone plus thalidomide in patients older than 75 years with newly diagnosed myeloma... CONCLUSION: This trial confirms the superiority of the combination melphalan and prednisone plus thalidomide over melphalan and prednisone alone for prolonging survival in very elderly patients with newly diagnosed myeloma. Toxicity was acceptable.
The treatment of multiple myeloma using vincristine, carmustine, melphalan, cyclophosphamide, and prednisone (VBMCP) alternating with high-dose cyclophosphamide and alpha(2)beta interferon versus VBMCP: results of a phase III Eastern Cooperative Oncology Group Study E5A93. [2009.05.15]
BACKGROUND: A randomized controlled trial tested the hypothesis that aggressive initial therapy using high-dose cyclophosphamide (HiCy) and alpha(2)beta interferon (IFN) may be superior to standard combination alkylating agent regimens in the treatment of newly diagnosed myeloma... CONCLUSIONS: The study showed no significant benefit with the addition of HiCy and IFN to VBMCP.
Thalidomide-dexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma. [2009.04.09]
We compared thalidomide-dexamethasone (TD) with melphalan-prednisolone (MP) in 289 elderly patients with multiple myeloma (MM)... Toxicity was higher with TD, particularly in patients older than 75 years with poor performance status.
Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. [2008.10.15]
The initial analysis of the oral combination melphalan, prednisone, and thalidomide (MPT) in newly diagnosed patients with myeloma showed significantly higher response rate and longer progression-free survival (PFS) than did the standard melphalan and prednisone (MP) combination and suggested a survival advantage...
Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. [2008.08.28]
BACKGROUND: The standard treatment for patients with multiple myeloma who are not candidates for high-dose therapy is melphalan and prednisone. This phase 3 study compared the use of melphalan and prednisone with or without bortezomib in previously untreated patients with multiple myeloma who were ineligible for high-dose therapy... CONCLUSIONS: Bortezomib plus melphalan-prednisone was superior to melphalan-prednisone alone in patients with newly diagnosed myeloma who were ineligible for high-dose therapy. (ClinicalTrials.gov number, NCT00111319.) 2008 Massachusetts Medical Society
Clinical Trials Related to Alkeran (Melphalan)
Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma [Terminated]
In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been
usedsince the 1960s and is regarded as the standard of care in very elderly patients. We
assess whether the addition of thalidomide at 100 mg/day to this combination would improve
survival.
Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients [Completed]
1. To evaluate the toxicity and safety of a combination of arsenic trioxide with ascorbic
acid and high-dose Melphalan in patients with multiple myeloma
2. To evaluate the efficacy of a combination of arsenic trioxide with ascorbic acid and
high-dose Melphalan in patients with multiple myeloma
3. To determine the effects of arsenic trioxide on melphalan pharmacokinetics
Phase II Trial of a Chemotherapy Alone Regimen of IV Busulfan (Busulfex), Melphalan and Fludarabine as Myeloablative Regimen Followed by an Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplant From an HLA-Identical, or HLA-Non Identical Related or Unrelated Donor [Active, not recruiting]
The purpose of this research study is:(1) to determine if high doses of chemotherapy without
total body irradiation can allow selected stem cells to take and grow,(2) to determine if
selected stem cells from the blood or marrow can take and not cause a complication called
graft-versus-host disease (GvHD) and (3) to evaluate the side effects of the combination of
chemotherapy drugs used for these transplants. In the last 10 years we have developed
chemotherapy combinations to be used for this T-cell depleted transplant protocol. By using
three chemotherapy drugs (IV busulfan, melphalan and fludarabine), we hope to have a good
chemotherapy combination to kill cancer cells, and to make the graft take, without the side
effects of total body irradiation. The chemotherapy drugs to be tested in this protocol are
busulfan, melphalan and fludarabine, all of which have been used successfully for stem cell
transplantation, but not given together as in this specific regimen. This is what is being
tested in this study.
Our initial trials in the 1980's with T-cell depleted transplants showed less GvHD, but the
overall results of the transplants were not better. The reason for this was that the stem
cells did not take and engraft in 15% of our adult patients. This failure of the stem cells
to take can leave patients without bone marrow or blood cells necessary for life. Most stem
cell transplants were done using bone marrow (BMA) obtained from the donors. However, if we
give a medication called G-CSF by shots to the donor, we can collect peripheral blood stem
cells (PBSC) and use them for transplant. The advantage of this approach is that we can
collect 2-20 times more stem cells than that obtained from the marrow. It has been proven
that a larger number of stem cells in the graft make it more difficult for the patient to
reject the stem cells. Some donors may be too small to provide peripheral blood stem cells or
they may not want to take G-CSF shots. In these cases the donors will have their marrow
collected in the operating room under general anesthesia.
Stem cell transplants can lead to a condition known as acute graft-versus-host disease or
GvHD. This disease is caused by an assault by certain cells in the marrow or blood (T-cells)
of the donor (graft) against your body (the host). These T-cells see your body as foreign and
attack it. The disease causes a skin rash, liver disease, and diarrhea. Methods were
developed at this institution to prevent GvHD. These methods take out most of the T-cells
(responsible for GvHD) from the marrow or blood stem cells before transplant. This is called
"T-cell depletion" or "stem cell selection". In this hospital, we use two types of methods of
T-cell depletion: one method is used with peripheral blood stem cells and one for bone
marrow. Both these techniques have been successful in preventing both acute and chronic GvHD.
You will receive a T-cell depleted stem cell transplant.
Velcade®-Melphalan Association in Autologous Stem-Cell Transplantation (ASCT) [Active, not recruiting]
Intensification with autologous stem cell (ASCT) is currently the most effective treatment
for subjects under 65 and the essential goal is to achieve complete response (CR) or very
good partial response (VGPR= greater than 90% reduction of monoclonal component). However,
only 50% of patients achieve this CR/VGPR even with tandem ASCT early in the course of
disease.
Optimization of the conditioning regimen could improve this CR/VGPR rate. The combinaison of
Velcade and HD Melphalan has never been evaluated. However, at conventional doses, Velcade
potentiates the antimyeloma effect of Melphalan without inducing any common toxicity.
This study will be conducted in patients under the age of 65 with de novo multiple myeloma or
in first relapse, with Salmon and Durie stage of III, II, I with one symptomatic bone lesion
(radiological)and no contraindication to intensification. The primary objective will be to
increase the CR/VGPR rate 3 months after autologous peripheral blood stem cell
transplantation conditioned by Velcade-Melphalan from 40% to 70%. With alpha=5% and bêta=10%,
61 patients will be included.
Secondary objectives will be to assess the toxicity of the Velcade-Melphalan conditioning
regimen, the progression-free survival and the overall survival after intensification.
Response rates will be evaluated according to the response criteria defined by. Analysis will
be performed on an intention-to-treat basis.
After conventional induction therapy and PBSC collection, patients will be offered this new
conditioning regimen. they will be free to refuse this regimen, in which case they will
receive standard intensification therapy by Melphalan 200 mg/m² followed by autologous stem
cell transplantation.
Evaluation will occur at 3 months post intensification.
A Pharmacokinetic Study of Melphalan HCL for Injection (Propylene Glycol-Free) and Alkeran for Injection for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation [Not yet recruiting]
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