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RMPT for Relapsed/Refractory Multiple Myeloma

2014-07-23 21:13:36 | BioPortfolio

Summary

After the discovery of melphalan and prednisone (MP), many clinical trials evaluated the efficacy of combination chemotherapy, such as VMCP, VBAP, MOCCA in multiple myeloma (MM) patients, without significant clinical benefit. After 40 years, the combination of MP with thalidomide (MPT) or lenalidomide (MPR) or bortezomib (MPV) have finally and consistently shown additive or synergistic effects.In advanced MM, the combination of melphalan, prednisone and thalidomide induced 12% very good partial response (VGPR) rate, while the combination of melphalan and bortezomib showed 15% near complete remission (nCR) rate. In relapsed patients, the combination of bortezomib with MPT (VMPT) induced 43% VGPR rate. Preliminary results indicate that VMPT may induce a CR rate of around 50% in newly diagnosed patients (unpublished results).In preclinical studies thalidomide showed more anti-angiogenesis activity, while lenalidomide showed more immunomodulatory effects, thus suggesting a combined clinical approach for these two drugs. The toxicity profile of lenalidomide is completely different from that of thalidomide and no cumulative toxicities are expected, again suggesting a combination approach. This study will evaluate the safety and efficacy of combining Lenalidomide, Melphalan, Prednisone and Thalidomide (R-MPT) as salvage treatment for relapsed/refractory myeloma patients. This association might further increase the response rate achieved by the standard oral MPT or MPR regimens.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Multiple Myeloma

Intervention

Revlimid, Melphalan, Prednisone, Thalidomide, Revlimid, Melphalan, Prednisone, Thalidomide

Location

Azienda Ospedaliera S Giovanni Battista
Torino
Italy/Torino
Italy
10126

Status

Active, not recruiting

Source

Fondazione Neoplasie Sangue Onlus

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:36-0400

Clinical Trials [1381 Associated Clinical Trials listed on BioPortfolio]

Revlimid And Prednisone Followed By Revlimid, Melphalan And Prednisone In Multiple Myeloma Patients

This study will determine whether the association of Revlimid and Prednisone (RP) as induction treatment followed by Revlimid, Melphalan and Prednisone (MPR) as consolidation treatment is...

Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma

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 whethe...

Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

RATIONALE: Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from div...

Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone in Elderly Myeloma Patients

The purpose of this study is to determine whether the association of Thalidomide to Melphalan and Prednisone is effective in the treatment of newly diagnosed elderly multiple myeloma.

Melphalan, Prednisone, and CC-5013 (Revlimid) as Induction Therapy in Multiple Myeloma

The purpose of this study is to evaluate the safety and efficacy of the association of Melphalan/Prednisone/Revlimid (MPR) as induction treatment for newly diagnosed myeloma patients over ...

PubMed Articles [130 Associated PubMed Articles listed on BioPortfolio]

A validated LC-MS/MS method for the simultaneous determination of thalidomide and its two metabolites in human plasma: Application to a pharmacokinetic assay.

An accurate and sensitive LC-MS/MS method for determining thalidomide, 5-hydroxy thalidomide and 5'-hydroxy thalidomide in human plasma was developed and validated using umbelliferone as an internal s...

Thalidomide induces apoptosis during early mesodermal differentiation of human induced pluripotent stem cells.

Thalidomide was once administered to pregnant women as a mild sedative; however, it was subsequently shown to be strongly teratogenic. Recently, there has been renewed interest in thalidomide because ...

CUL5 is required for thalidomide-dependent inhibition of cellular proliferation.

Angiogenesis is essential for cancer metastasis, thus the discovery and characterization of molecules that inhibit this process is important. Thalidomide is a teratogenic drug which is known to inhibi...

Comparison of two melphalan protocols and evaluation of outcome and prognostic factors in multiple myeloma in dogs.

Multiple myeloma (MM) in dogs typically is treated with melphalan. A daily melphalan dosing schedule reportedly is well tolerated and associated with favorable outcome. Although anecdotally a pulse do...

Preparation, characterization, in vitro and in vivo anti-tumor effect of thalidomide nanoparticles on lung cancer.

Thalidomide (THA) is an angiogenesis inhibitor and an efficient inhibitor of the tumor necrosis factor-α (TNF-α). However, the clinical application of THA has been limited due to hydrophobicity of t...

Medical and Biotech [MESH] Definitions

A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppresive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.

An alkylating nitrogen mustard that is used as an antineoplastic in the form of the levo isomer - MELPHALAN, the racemic mixture - MERPHALAN, and the dextro isomer - MEDPHALAN; toxic to bone marrow, but little vesicant action; potential carcinogen.

A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.

An antineoplastic agent used primarily in combination with mechlorethamine, vincristine, and prednisone (the MOPP protocol) in the treatment of Hodgkin's disease.

A mixture of six synthetic oligopeptides, each containing MELPHALAN. It is used as a broad-spectrum antineoplastic due to its alkylating and antimetabolic actions but, is toxic to bone marrow, gastrointestinal system and vasculature.

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