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

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Cyclophosphamide

Prednisone

Lenalidomide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Angiogenesis Inhibitors

Growth Inhibitors

Lenalidomide orally on Days 1-21 followed by 7 days rest, repeated every 28 days.

Cyclophosphamide twice daily, orally on Days 1-21 followed by 7 days rest, repeated every 28 days.

Prednisone every other day orally.

25 mg p.o. daily on days 1-21 of each 28 day cycle

lenalidomide (Revlimid®)

50 mg p.o. BID daily on days 1-21 of each 28 day cycle

Attaya Suvannasankha, M.D.

The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.

This is a phase II single institution trial in patients with newly diagnosed multiple myeloma. Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D..

Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma

Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma

Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.

Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.

Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.

Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome

Celgene

Attaya Suvannasankha

Assistant Professor of Medicine

Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.

Original Study - Revlimid, Cyclophosphamide, Prednisone

Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.

Extension - Revlimid, Cyclophosphamide, Prednisone

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Attaya Suvannasankha

All patients receiving at least one dose of study drug and having at least one post-baseline visit

Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria

All patients enrolled and received treatment.

Treatment Related Adverse Events Grade 3 or Higher

Physical Well-Being Change from Baseline

Social/Family Well-Being Change from Baseline

Emotional Well-Beling Change from Baseline

Functional Well-Being Change from Baseline

FACT-G Change from Baseline

All patients enrolled and received treatment with a baseline and post-baseline measurement.

Quality of Life Using the FACT-G Data

Overall Study

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Dexamethasone

Melphalan

Bortezomib

Dexamethasone acetate

BB 1101

Busulfan

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

bortezomib/lenalidomide/dexamethasone (VRD-GEM) induction treatment followed by high-dose melphalan-200 (MEL-200)

bortezomib/lenalidomide/dexamethasone (VRD-GEM) induction treatment followed by busulfan-melphalan (BUMEL) chemotherapy and consolidation with VRD-GEM

bortezomib (Velcade ®)

busulfan (Busilvex ®)

This protocol is a national, multicenter, comparative, open-label, randomized trial comparing the progression free survival (PFS) of two pre-transplant conditioning regimens (BUMEL versus. MEL-200).

A total of 460 patients will be enrolled in the study. Scheduled evaluations and study visits will take place during the pre-treatment, treatment and follow-up periods.

The pre-treatment period includes the screening visit in which participants provide informed consent in writing in order to take part in the study. The patient is then assessed to determine his/her eligibility. The selection process will begin 21 days before the first dose of medication is administered (days -21 to 0). During the treatment period, eligible patients will be included in the study and given six cycles of induction treatment with bortezomib/ lenalidomide / dexamethasone (VRD-GEM). Each cycle will last 28 days, during which SC bortezomib will be administered on days 1, 4, 8 and 11, oral lenalidomide on days 1-21 of each cycle, and oral dexamethasone on days 1-4 and 9-12 of the cycle.

After the first three induction cycles, and in the absence of progression or unacceptable toxicity, peripheral blood hematopoietic stem cells will be mobilized and collected using G-CSF for later autologous transplantation. Patients will be randomized in a 1:1 allocation ratio to receive conditioning treatment with MEL-200 versus BUMEL. Randomization will take place at the beginning of the study, once the screening is complete and the patient's eligibility verified. Three months after transplantation, patients will receive two cycles of consolidation treatment with VRD-GEM at the same doses administered during induction treatment.

Once the treatment phase is complete, patients will begin the follow-up phase in which they will be visited every three months to evaluate disease progression and survival

Bortezomib (Velcade®), Lenalidomide (Revlimid®) and IV Busulfan (Busilvex®) in Patients Under 65 Years Old

A Randomized, National, Open-label, Multicenter, Phase III Trial Studying Induction Therapy With Bortezomib/Lenalidomide/Dexamethasone (VRD-GEM), Followed by High-dose Chemotherapy With Melphalan-200 (MEL-200) Versus Busulfan-melphalan (BUMEL), and Consolidation With VRD-GEM in Patients Under 65 Years Old With Newly-diagnosed, Symptomatic Multiple Myeloma

Janssen, LP

Pierre Fabre Medicament

PETHEMA Foundation

Symptoms and General Pathology

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Cytarabine

Idarubicin

Antimetabolites

Antiviral Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.

Idarubicin: 12 mg/m\^2.

Cytarabine: 200 mg/m\^2.

Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.

Idarubicin: 12 mg/m\^2.

Cytarabine: 200 mg/m\^2.

Lenalidomide: Maximum Tolerated Dose (MTD).

Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Lenalidomide as outlined in Phase I and Phase II Treatment Arms.

Lenalidomide (Revlimid®)

Jeffrey Lancet, M.D.

The purpose of this study is to:

* Test the safety of the research study drug, lenalidomide, when given with Idarubicin and Cytarabine
* See how many respond to combination treatment with lenalidomide, Idarubicin and Cytarabine
* See how long people respond to this combination therapy
* See how long people live after being treated with this combination of drugs

All three drugs are FDA approved to treat patients in the United States of America. Idarubicin and Cytarabine combination therapy is a standard treatment for patients with acute myeloid leukemia (AML). Lenalidomide is FDA approved to retreat patients with Multiple Myeloma or Myelodysplastic syndrome with a specific change in their DNA. Loss of a specific part of DNA is also seen in some patients with AML.

This is a phase 1/2, dose-escalation trial of Lenalidomide given in combination with idarubicin + cytarabine. During phase 1, we will enroll patients with AML involving del 5q31; 2) patients with MDS RAEB-2 associated with monosomy 5 or segmental deletion involving 5q31, either alone or with additional cytogenetic abnormalities, and 3) older patients with any type of karyotypic profile in whom an effective and reliable standard of care remains to be developed. All 3 groups of patients define a population of patients with very poor prognoses. Dose escalation of lenalidomide will use a standard 3x3 design. Dose escalation of Lenalidomide only will take place, while the doses of idarubicin and cytarabine will be constant. This trial will have an induction component, consolidation component, and maintenance component. Overall safety and MTD will be determined from the induction phase only.

During phase 2, we will enroll only patients with AML age ≥ 60 years. During phase 2, the efficacy of this combination of Lenalidomide + idarubicin + cytarabine, at the maximum tolerated dose (MTD) for Lenalidomide (determined during phase 1), will be tested.

Idarubicin + Cytarabine and Lenalidomide in Patients With Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML)

A Phase 1/2 Study of Sequential Idarubicin + Cytarabine, Followed by Lenalidomide, in Patients With Myelodysplastic Syndrome (RAEB-2) or With Previously Untreated Acute Myeloid Leukemia

Rate of cytogenetic remission following induction therapy. Descriptive analysis was planned for this measure.

Relapse-Free Survival (RFS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be analyzed similarly. Descriptive analysis was planned for this measure.

For the Phase I component, no formal statistical analysis was planned. The primary endpoint is to determine the maximum tolerated dose (MTD) and recommended Phase II dose of lenalidomide given in combination with standard idarubicin + cytarabine induction therapy.

Percentage of participants achieving CR/CRi. Complete Response (CR) plus Complete Response with Incomplete Count Recovery (CRi) rates. Response rates (CR + CRi) of lenalidomide following idarubicin and cytarabine induction therapy in older patients with previously untreated AML. A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of 100,000/μL. CRi: After chemotherapy, patients fulfill all of the criteria for CR except for residual neutropenia (1,000/μL) or thrombocytopenia (100,000/μL).

Rate of toxicities of lenalidomide as maintenance therapy according to the National Cancer Institute Common Toxicity Criteria (CTC) V3. Adverse Events: Possibly Related; Probably Related, or Definitely Related to study treatment. Events are categorized as Grade 1 or 2, or as Grade 3 or 4.

Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse, or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve.

Overall Survival (OS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, to be analyzed similarly. Descriptive analysis was planned for this measure.

H. Lee Moffitt Cancer Center and Research Institute

All Serious Adverse Events (SAEs) are reported, regardless of causality. All Other (not including Serious) Adverse Events (AEs) meeting 5% frequency threshold are reported, regardless of causality.

Phase I: Dose Escalation

Phase II: Treatment at MTD

Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.

Idarubicin: 12 mg/m\^2.

Cytarabine: 200 mg/m\^2.

Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.

Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms.

Idarubicin: 12 mg/m\^2.

Cytarabine: 200 mg/m\^2.

Lenalidomide: Maximum Tolerated Dose (MTD).

Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms.

United States

Region of Enrollment

All participants enrolled, according to study phase. Outcome measure groups may vary depending on the analysis required.

Dr. Jeffrey Lancet

Phase I Participants

Phase I: Recommended Phase II Dose

All participants, regardless of Phase who were treated at the maximum tolerated dose (MTD).

All Participants Treated at MTD

Phase II: Complete Response Rate of Participants Treated at Maximum Tolerated Dose (MTD)

Leukocytes (total WBC) - low - Grade 1 or 2

Leukocytes (total WBC) - low - Grade 3 or 4

ANC/AGC - Grade 1 or 2

ANC/AGC - Grade 3 or 4

Platelets - low - Grade 1 or 2

Platelets - low - Grade 3 or 4

Fatigue - Grade 1 or 2

Fatigue - Grade 3 or 4

Dry skin - Grade 1 or 2

Dry skin - Grade 3 or 4

Pruritus/itching - Grade 1 or 2

Pruritus/itching - Grade 3 or 4

Rash/desquamation - Grade 1 or 2

Rash/desquamation - Grade 3 or 4

Constipation - Grade 1 or 2

Constipation - Grade 3 or 4

Diarrhea - Grade 1 or 2

Diarrhea - Grade 3 or 4

Nausea - Grade 1 or 2

Nausea - Grade 3 or 4

Ulcer, GI - Anus - Grade 1 or 2

Ulcer, GI - Anus - Grade 3 or 4

Hemorrhage, GI - Rectum - Grade 1 or 2

Hemorrhage, GI - Rectum - Grade 3 or 4

Infection - Skin (cellulitis) Grade 1 or 2

Infection - Skin (cellulitis) Grade 3 or 4

AST, SGOT - Grade 1 of 2

AST, SGOT - Grade 3 or 4

Pain - Head/headache - Grade 1 or 2

Pain - Head/headache - Grade 3 or 4

All participants treated in the Maintenance Phase.

Maintenance Phase Participants

Rate of Lenalidomide Related Toxicity During Maintenance Therapy

Median Progression-Free Survival (PFS)

Median Overall Survival (OS)

Rate of Cytogenetic Remission Following Induction Therapy

Median Relapse-Free Survival (RFS)

Lymphoma

Hodgkin Disease

Lymphatic Diseases

Lymphosarcoma

Hodgkin Lymphoma

Lenalidomide given as a daily oral dose of 25 mg on days 1 - 21 followed by 7 days of no therapy of a 28 day cycle in the treatment of a population with relapsed or refractory Hodgkin's lymphoma.

25mg PO daily for 21 out of 28days per cycle

John Kuruvilla

This is a single-arm, open-label Phase II study evaluating the activity of Lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.

While the results of primary therapy for Hodgkin's lymphoma are generally excellent, between 10-20% of patients with advanced stage disease will not enter a complete remission (CR) and between 20-30% of patients will relapse after completion of treatment. Salvage chemotherapy followed by high dose chemotherapy and autologous stem cell transplantation (ASCT) has become the treatment of choice in patients with relapsed or initially chemotherapy-refractory disease.

Although high dose chemotherapy remains a curative option for the treatment of relapsed or chemotherapy-refractory Hodgkin's lymphoma, up to 50% of patients will ultimately recur post-stem cell transplant and will require further treatment.

Thalidomide is an agent that has anti-inflammatory, immunomodulatory and anti-angiogenic properties. Thalidomide has been shown to have activity in a number of solid and hematologic malignancies, and has demonstrated effectiveness in the treatment of refractory multiple myeloma. A dose escalation study of single-agent thalidomide has been performed in heavily pre-treated patients in which two Hodgkin's patients were enrolled and did not respond to treatment. Based on the NCI experience with vinblastine, we initiated a phase II trial examining the combination of thalidomide and vinblastine in patients who were being treated palliatively for Hodgkin's lymphoma. In a heavily pre-treated group of patients (70% of cases having relapsed post-ASCT), a response rate of 40% to the combination was noted with median duration of response of over nine months.

Lenalidomide (Revlimid®) is a thalidomide derivative and the first-in-class novel immunomodulatory agent that has more potent activity as well as a more favourable toxicity profile than the parent compound. Based on the alterations demonstrated in various cytokines and angiogenic markers in patients with Hodgkin's lymphoma, we feel that Lenalidomide's immunomodulatory and anti-angiogenic effects make this an ideal drug to study in this lymphoma. This will be the first study to assess Lenalidomide in patients with Hodgkin's lymphoma.This is a single arm, open-label phase II multi-centre study evaluating the single agent activity of Lenalidomide in relapsed or refractory Hodgkin's lymphoma. The primary endpoint is objective response rate (CR + CRu + PR) as determined by International Workshop Criteria.

Initial treatment will consist of lenalidomide 25 mg PO daily given for 21 consecutive days (days 1 - 21), with seven days off on a 28 day cycle.Patients with PR, CR or CRu, may continue on therapy for 2 cycles past best response.Patients with PD at any time or those with evidence of SD after cycle 4 of monotherapy will be eligible to receive treatment with dexamethasone 40 mg PO daily on days 1 - 4 and 15 - 18 of a 28 day cycle while continuing protocol treatment if they continue to meet the criteria of continuation on therapy.

Phase II Study of Lenalidomide for the Treatment of Relapsed or Refractory Hodgkin's Lymphoma

Celgene Corporation

University Health Network, Toronto

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma	NCT00540644	Multiple Myelom...	lenalidomide (R... Cyclophosphamid... Prednisone	18 Years -	Indiana University
Bortezomib (Velcade®), Lenalidomide (Revlimid®) and IV Busulfan (Busilvex®) in Patients Under 65 Years Old	NCT01916252	Multiple Myelom...	bortezomib (Vel... lenalidomide (R... busulfan (Busil... Dexamethasone a... Melphalan	18 Years - 65 Years	PETHEMA Foundation
Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma	NCT00540644	Multiple Myelom...	lenalidomide (R... Cyclophosphamid... Prednisone	18 Years -	Indiana University
Idarubicin + Cytarabine and Lenalidomide in Patients With Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML)	NCT00831766	Myelodysplastic... Acute Myeloid L...	Idarubicin Cytarabine Lenalidomide (R...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Phase II Study of Lenalidomide for the Treatment of Relapsed or Refractory Hodgkin's Lymphoma	NCT00478959	Hodgkin Disease	Lenalidomide (R...	18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for lenalidomide (revlimid®)