Thalomid Clinical Studies - Thalidomide Clinical Studies - Myeloma


What have Thalomid clinical studies shown?

Is Thalomid effective in previously untreated myeloma?

Thalomid® (thalidomide, Celgene) clinical studies have shown that adding Thalomid to one or more other drugs to treat newly diagnosed/untreated multiple myeloma has improved response rates and survival time. Combination therapies that include Thalomidhave been shown to be effective for both patients who are to have stem cell transplantation and those who are not.

Three studies have shown that the combination of Thalomid, melphalan, and prednisone (MPT) leads to better outcomes than MP alone in patients not eligible for stem cell transplantation. In a study of 447 patients, MPT led to a higher overall survival rate (52%) than MP alone (33%); the rate of partial response was 76% for MPT compared with 35% for MP alone. Two other studies also demonstrated higher response rates among patients treated with MPT. However, MPT is now being used less frequently for the treatment of myeloma.

Two large studies in patients not eligible for stem cell transplantation have shown Thal-dex to be more effective than dexamethasone alone. In a study of 207 patients, the overall response rate was higher for Thal-dex (63%) than for dexamethasone alone (41%). A larger study showed similar rates, as well as a longer 3-year survival rate (80% compared with 64%) and a longer time to disease progression (23 months compared with 7 months).

Several studies have shown the combination of Thal-dex plus Velcade® (bortezomib, Takeda Oncology) to be more effective than Thal-dex when given prior to stem cell transplantation. For example, in one study involving 255 patients, Thal-dex plus bortezomib led to a complete response (before transplantation) of 36% compared with 9% for Thal-dex alone. The rate of complete response after transplantation was 57% for Thal-dex plus bortezomib and 28% for Thal-dex alone.

Is Thalomid effective for maintenance therapy?

The use of Thalomid for maintenance therapy following stem cell transplantation or conventional chemotherapy has been investigated in several studies. Thalomid alone or in combination with dexamethasone or prednisone has maintained progression-free survival and has improved overall survival. However, the long-term use of Thalomid, especially at higher doses, may cause side effects that necessitate discontinuation of treatment. A dose of 200 mg or less has been found to be tolerable as maintenance therapy.

Is Thalomid effective for relapsed/refractory myeloma?

Thalomid is used alone and in combination with a variety of other agents in the treatment of relapsed/refractory myeloma. In clinical studies in previously treated myeloma, Thal-dex has been shown to provide higher response rates compared with Thalomid alone. However, Thalomid alone may be an option for patients who cannot tolerate steroids. Combination therapy that includes Thal-dex and the chemotherapy agents cisplatin, doxorubicin, cyclophosphamide, and etoposide (referred to as DT-PACE), was shown to be an effective treatment for progressive disease. The combination of Thal-dex and Velcade was found to be more effective than Thal-dex in the treatment of patients who had disease progression following a stem cell transplant.