Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Doxorubicin

Liposomal doxorubicin

Lenalidomide

Dexamethasone acetate

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Revlimid

Ralf Bargou, MD

This is a multi-center, open label, uncontrolled, non-comparative phase I/II study in patients with refractory or relapsed multiple myeloma who are eligible for second, third, or fourth line therapy. Patients will be enrolled sequentially into four dose cohorts. The feasibility of administrating Revlimid (R) in combination with Doxorubicin and Dexamethasone (AD) and the MTD of the combination will be determined in the phase I part of the study (Part A). When the MTD has been established, the efficacy of the combination will be further evaluated in the phase II part of the study Part B)

Multiple myeloma is an incurable disease that is characterized by the malignant proliferation of plasma cells. It is the second most common hematological malignancy, is invariable fatal. The primary approach for treatment of multiple myeloma is systemic chemotherapy. Conventional chemotherapy with melphalan and prednisone (MP) has increased the survival from 12-17 months to approximately 3 years. But several other studies have shown that combination therapy with addition of other agents such as cyclophosphamide, nitroureas or anthracyclins does not improve the prognosis of patients with multiple myeloma. During the past few years it has been demonstrated that high dose chemotherapy followed by autologous stem cell transplantation can prolong the overall survival of myeloma patients and therefore became the standard of care for younger patients. Since it has been demonstrated that high dose chemotherapy is also well tolerated by the elderly high dose chemotherapy is recommended for patients up to an age of about 70 if there is no relevant comorbidity. Thus, the development of more effective regimens for the teatment of relapsed or refractory myeloma patients is urgently needed. Treatment with corticosteroids alone can induce responses in both primarily resistant and relapsed patients with myeloma. High pulse dexamethasone (40mg daily d1-4, 9-12 and 17-21) showed response rates of 27% in primarily unresponsive patients and 21% in relapsed patients, which were initially responsive. In combination with anthracyclins like in the VAD-regimen (vincristin, adriamycin, dexamethasone)response rates of about 31% were achieved in primary unresponsive patients whereas the response rate was 65% in patients who relapsed, but had previously responded to therapy. Thus, the combination of dexamethasone with anthracyclines and vincristin achieve a certain anti-myeloma activity in relapsed or refractory patients. Nevertheless due to the neurotoxicity, treatment with vincristin of elderly patients is critical and limited. Therefore substitution of vincristine by a less toxic agent with high anti-myeloma activity like the new thalidomide analogues (see below) could reduce toxicity and improve the therapeutic efficacy of anthracycline and dexamethasone containing regimens. Protocol DSMM VII Page 7/52 29.09.2004 Version 1.1 dexamethasone containing regimens. One interesting drug with substantial anti-myeloma activity in patients with relapsed or refractory myeloma is thalidomide. Thalidomide has been demonstrated to induce remissions in about one third of relapsed myeloma patients if given as a single agent therapy. Response rates evaluated in phase-II studies could be improved up to 55% if thalidomide was administered in combination with other drugs such as glucocorticoids. However substantial side effects were observed such as somnolence, constipation and neuropathy. These observations led to development of derivatives of thalidomide in order to reduce toxicity and to improve efficacy. The thalidomide analogues represent a new class of active drugs based on immunmodulatory and direct anti-myeloma effects which have been demonstrated to have a greater potency to inhibit growth of MM and angiogenesis in vitro and in vivo than thalidomide. In a phase I study heavily pretreated patients with relapsed or refractory myeloma were treated with CC-5013 (RevlimidTM, lenalidomide). Revlimid at doses up to 25 mg/day was safe and well tolerated. The dose-limiting toxicity (DLT) was myelosupression at a dose level of 50 mg/day. In contrast to thalidomide treatment with CC- 5013 showed no significant side effects like somnolence, constipation or neuropathy. In addition 29 % of the subjects achieved a \> 50% paraprotein reduction, 71% a reduction of \> 25%. Preliminary phase II data showed in about 20 % of relapsed myeloma patients a \> 50% reduction of paraprotein, a \> 25% reduction could be observed in about 50%. No additional toxicity was observed in combination with dexamethasone. Thus, Revlimid as a single agent is well tolerated and has a profound anti-myeloma activity in patients with refractory or relapsed disease. These data suggest that Revlimid combined with chemotherapy could lead to enhanced anti-myeloma effects with acceptable toxicities. The present study will investigate the safety and the efficacy of intermittent dosing of CC-5013 (Revlimid) combined with Dexamethasone and Doxorubicin in the treatment of relapsed or refractory myeloma. Objectives Primary Objectives

Evaluation of Lenalidomide, Doxorubicin and Dexamethasone (RAD) in Patients With Relapsed or Refractory Multiple Myeloma

A Multicenter Phase I/II Trial Evaluating the Safety and Efficacy of Lenalidomide (Revlimid, CC-5013) in Combination With Doxorubicin and Dexamethasone (RAD) in Patients With Relapsed or Refractory Multiple Myeloma

University of Wuerzburg

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Carboplatin

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

5mg/day RAD001 + Carboplatin + Paclitaxel

30mg/week RAD001 + Carboplatin + Paclitaxel

5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab

30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab

5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm

RAD001

Novartis Pharmaceuticals

This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD 001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in combination with carboplatin, paclitaxel and bevacizumab

This is a two-step, open-label, multi-center, dose escalation Phase 1 study in which RAD001 is administered in combination with carboplatin and paclitaxel (CP) in Step 1 as well as carboplatin, paclitaxel, and bevacizumab (CPB) in Step 2 in patients with advanced (unresectable or metastatic) NSCLC not treated previously with systemic therapy for advanced disease

Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients

A Two-step Phase 1 Study Investigating the Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients Not Treated Previously With Systemic Therapy

Small Cell Lung Carcinoma

Small Cell Lung Cancer

Etoposide

Cisplatin

Etoposide phosphate

Lactitol

RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language.

This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.

Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients

A Phase Ib Study Investigating the Combination of RAD001 With Cisplatin and Etoposide in Patients With Extensive-stage Small-cell Lung Cancer Not Previously Treated With Chemotherapy

Fludarabine

Fludarabine phosphate

Melphalan

Treosulfan

Second scheduled transplantation performed from an HLA-matched MRD or MUD after conditioning with treosulfan and fludarabine

Second high-dose melphalan therapy followed by transplantation of peripheral blood stem cells

Transplantation of stem cells from a MRD or MUD, respectively after dose-reduced conditioning versus autologous stem cell graft after preparation with melphalan 200 mg/m²

allogeneic stem cell transplant versus second autologous transplantation

After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone.

Ralf C Bargou, MD

Subjects up to the age of 65 years with newly diagnosed multiple myeloma requiring treatment are eligible. Minimal pretreatment (2 cycles of chemotherapy; local irradiation; surgery) is permitted. After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone. If at least a minimal response is achieved to RAD, they will undergo chemomobilization (cyclophosphamide, etoposide) of peripheral blood stem cells and one uniform cycle of high-dose melphalan chemotherapy followed by a first stem cell transplant. If any of the high-risk features (such as elevated beta 2-microglobulin, adverse cytogenetic factors, elevated LDH, Ig A isotype) were present at diagnosis, patients will be allocated to a consolidative allogeneic transplant following dose-reduced conditioning. If no appropriate donor is available, the patient does not consent or lacks of high-risk features a second autograft following high-dose melphalan will be delivered. All patients will proceed to lenalidomide maintenance (one year) following hematopoietic reconstitution.

Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma

Lenalidomide (Revlimid®), Adriamycin and Dexamethasone (RAD)as an Induction Therapy in Newly Diagnosed Multiple Myeloma Followed by a Risk-Defined Transplant Strategy and Lenalidomide Maintenance - A Multicenter Phase II Trial by Deutsche Studiengruppe Multiples Myeloma (DSMM XII)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Lenalidomide, Doxorubicin and Dexamethasone (RAD) in Patients With Relapsed or Refractory Multiple Myeloma	NCT00306813	Relapse Refractory Mult...	Revlimid	18 Years -	University of Wuerzburg
Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients	NCT00457119	Non Small Cell ...	RAD001	23 Years - 76 Years	Novartis
Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients	NCT00466466	Small-Cell Lung...	Everolimus	18 Years -	Novartis
Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients	NCT00457119	Non Small Cell ...	RAD001	23 Years - 76 Years	Novartis
Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma	NCT00925821	Multiple Myelom...	allogeneic stem... RAD	18 Years - 65 Years	Wuerzburg University Hospital

Spots Global Cancer Trial Database for rad

Every month we try and update this database with for rad cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rad

Every month we try and update this database with for rad cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rad cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.