thalidomide and Chromosome Deletion

thalidomide has been researched along with Chromosome Deletion in 194 studies

Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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 immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.
thalidomide : A racemate comprising equimolar amounts of R- and S-thalidomide.
2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione : A dicarboximide that is isoindole-1,3(2H)-dione in which the hydrogen attached to the nitrogen is substituted by a 2,6-dioxopiperidin-3-yl group.

Chromosome Deletion: Actual loss of portion of a chromosome.

Research

Studies (194)

Authors

Clinical Trials (24)

Trial Overview

Trial Outcomes

Overall Incidence of Adverse Events

Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study. (NCT00179647)
Timeframe: Median time-on-study=18.3 weeks

Apparent Terminal Elimination Rate Constant of Lenalidomide

Apparent terminal elimination rate constant of lenalidomide determined after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Apparent Total Plasma Clearance (CL/F) of Lenalidomide

Apparent total plasma clearance (CL/F) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Apparent Volume of Distribution (VzF) of Lenalidomide

Apparent volume of distribution of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Lenalidomide

Area under the plasma concentration-time curve from time zero to infinity (AUC∞) of lenalidomide after a single dose on Day 1. (NCT00812968)
Timeframe: Day 1 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Lenalidomide

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUCt) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Lenalidomide

Area under the plasma concentration-time curve over the dosing interval (AUCτ) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.

Maximum Observed Plasma Concentration (Cmax) of Lenalidomide

Maximum observed plasma concentration of lenalidomide after a single dose on Day and after multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Terminal Half-life (T1/2) of Lenalidomide

The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Time to Maximum Plasma Concentration (Tmax) of Lenalidomide

Time to maximum observed plasma concentration of lenalidomide after a single dose on Day 1 and multiple doses (Day 4). (NCT00812968)
Timeframe: Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.

Change From Baseline in Hemoglobin Concentration

Change in hemoglobin concentration from Baseline to the maximum observed value during the major erythroid response period for major erythroid responders. (NCT00812968)
Timeframe: Baseline and from Day1 until the maximum observed value (up to 155 weeks)

Change From Baseline in Percentage of Bone Marrow Erythroblasts

Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section. (NCT00812968)
Timeframe: Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).

Duration of Erythroid Response

Duration of erythroid response was calculated as the time from the start of the first major or minor erythroid response to the end of the response. Similarly, duration of major erythroid response was calculated as the time from the start of the first major erythroid response to the end of the response. Response duration was censored at the last adequate assessment for patients who maintained response. (NCT00812968)
Timeframe: From the first dose of study drug through Week 156

Number of Participants With a Cytogenetic Response

"Cytogenetic (chromosome structure) abnormalities were assessed by a central cytogenetic reviewer based on prints and cytogenetic reports of the bone marrow sample from the central laboratory. Cytogenetic response was determined using the IWG (2000) criteria and categorized as either a major response or minor response. Twenty metaphases were analyzed for the determination of cytogenetic response.~A major response was defined as no detectable cytogenetic abnormality, if an abnormality was present at Baseline, sustained for consecutive 56 days during the treatment period. A minor response was defined as ≥ 50% reduction from Baseline in abnormal metaphases sustained for consecutive 56 days during the treatment period." (NCT00812968)
Timeframe: Response was assessed every 12 weeks through Week 156

Number of Participants With a Erythroid Response

"Erythroid response was determined using the International Working Group (IWG) 2000 criteria, categorized as a major response or minor response.~A major response in patients with transfusion-dependent anemia (receiving ≥ 4.5 units of red blood cell (RBC) transfusion during 56 consecutive days at Baseline) is defined as RBC transfusion independence accompanied by a ≥1.0 g/dL increase from Baseline in hemoglobin sustained for 56 days consecutively during the treatment period. In patients with transfusion-independent anemia with hemoglobin < 10 g/dL at Baseline a major response is defined as a > 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days.~Minor response in patients with transfusion-dependent anemia defined as ≥ 50% decrease from Baseline in transfusion requirements sustained for consecutive 56 days, and in transfusion-independent patients as 1.0 to 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days." (NCT00812968)
Timeframe: Response was assessed every 28 days through Week 156.

Number of Participants With a Neutrophil Response

"Neutrophil response was determined using the IWG (2000) criteria. A major response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase or a ≥ 500/mm^3 increase, whichever is greater, sustained for consecutive 56 days during the treatment period.~A minor response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase, but an absolute increase < 500/mm^3, sustained for consecutive 56 days during the treatment period." (NCT00812968)
Timeframe: Response was assessed every 28 days through Week 156

Number of Participants With Adverse Events (AE)

"An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event.~The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event.~The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death." (NCT00812968)
Timeframe: After the first study dose until 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).

Percentage of Bone Marrow Myeloblasts

Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section. (NCT00812968)
Timeframe: Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).

Percentage of Bone Marrow Promyelocytes

Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section. (NCT00812968)
Timeframe: Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).

Time to Erythroid Response

Time to erythroid response was calculated as the time from the first dose of study drug to the start of the first major or minor erythroid response. Similarly, time to major erythroid response was calculated as the time from the first dose of study drug to the start of the first major erythroid response. (NCT00812968)
Timeframe: From the first dose of study drug through Week 156

Number of Patients With Dose-limiting Toxicities and Treatment-emergent Adverse Events

To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma (NCT02661022)
Timeframe: For a 28-day cycle, Cycle 1

Number of Patients With Treatment-related Adverse Events

To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma (NCT02661022)
Timeframe: Up to 12 months

Overall Response Rate

Overall response rate is defined as complete response + very good partial response + partial response and clinical benefit rate (CR + VGPR + PR + minimal response [MR]) based on International Myeloma Working Group-defined response criteria and the duration of response (DOR) in relapsed refractory multiple myeloma (RRMM) patients. (NCT02661022)
Timeframe: Up to 12 Months

Progression-free Survival

Per International Myeloma Working Group Response Criteria, progression/progressive disease is defined as increase of >25% from lowest response value in any 1 of the following: serum M-component (the absolute increase must be >0.5 g/dL)4 and/or urine M-component (the absolute increase must be >200 mg/24 h) and/or; only in patients without measurable serum and urine M-protein, the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL; only in patients without measurable serum and urine M-protein and without measurable disease by FLC levels; bone marrow plasma cell percentage (absolute % must be ≥10%); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder. (NCT02661022)
Timeframe: Up to 12 Months

Treatment-Emergent Adverse Events Leading to Discontinuation of Study Drug

To evaluate the safety of single agent SL-401 in an initial run-in cycle in patients with multiple myeloma (MM) (NCT02661022)
Timeframe: Up to 12 Months

Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Endpoints at Week 12

"The Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire (Yellen, 1997) was used to assess health-related quality of life (HRQoL).~In addition to general HRQoL, the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning. The overall score range for the FACT-An is 0-188. Higher scores indicate better HRQoL." (NCT00179621)
Timeframe: Baseline, Week 12

Change From Baseline in the Trial Outcome Index-Anemia (TOI-An) Endpoints at Week 12

The Trial Outcome Index-Anemia (TOI-An) composed of the physical and functional subscales of the FACT-G along with the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-An is 0-136. Higher scores indicate better HRQoL. (NCT00179621)
Timeframe: Baseline, Week 12

Change From Baseline in the Trial Outcome Index-Fatigue (TOI-F) Endpoints at Week 12

The Trial Outcome Index-Fatigue(TOI-F) composed of the physical and functional subscales of the FACT-G along with the fatigue items from the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-F is 0-108. Higher scores indicate better HRQoL. (NCT00179621)
Timeframe: Baseline, Week 12

Duration of Red Blood Cell (RBC) Transfusion Independence for Participants Who Became RBC Transfusion Independent for at Least 182 Days

Mean number of weeks that participants who achieved RBC transfusion independence for at least 182 days were able to maintain RBC transfusion independence. Both double-blind and open-label periods are included. (NCT00179621)
Timeframe: up to 3 years

Kaplan Meier Estimates of Overall Survival by Randomized Group

Kaplan Meier estimate for median length of survival for study participants as they were randomized at the start of the study. (NCT00179621)
Timeframe: up to 3 years

Maximum Change From Baseline in Hemoglobin During the Double-blind Period for Participants Who Became Red Blood Cell (RBC) Transfusion Independent for at Least 182 Days

For participants who became RBC transfusion independent for at least 182 days during the double-blind study period, the mean maximum change from baseline in hemoglobin is summarized. (NCT00179621)
Timeframe: Baseline, up to 52 weeks

Participant Count of Deaths During Double-blind and Open-label by Randomized Group

Count of participant deaths throughout the entire study and reported by the original treatment assignment. (NCT00179621)
Timeframe: up to 3 years

Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for >= 26 Weeks (182 Days)

The count of study participants who had no RBC transfusions for 26 consecutive weeks or more during the double-blind period. (NCT00179621)
Timeframe: Up to 52 weeks

Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for 56 Days

Count of study participants who had no RBC transfusions during any 56 or more consecutive study days during the double-blind period. (NCT00179621)
Timeframe: Up to 52 weeks

Participants Showing Cytogenetic Response by the International MDS Working Group (IWG 2000) During Double-blind Period as Evaluated by Central Review

The IWG criteria for evaluating cytogenetic response require a minimum of 20 baseline and post-baseline analyzable metaphases using conventional cytogenetic techniques. A major cytogenetic response is defined as no detectable cytogenetic abnormality if preexisting abnormality was present whereas a minor response requires ≥50% reduction in abnormal metaphases. Progression could be concluded based on as few as 3 metaphases if there were additional abnormalities. The best response is represented. (NCT00179621)
Timeframe: up to 52 weeks

Participants Who Progressed to Acute Myeloid Leukemia (AML) During the Study

Number of participants who progressed to acute myeloid leukemia during the study, summarized at three different timepoints: first 16 weeks of the double-blind study, week 52 of the double-blind study, and up to 36 months which includes the double-blind and open-label periods of the study. The counts are cumulative by timeframe. (NCT00179621)
Timeframe: up to 3 years

Participants' Response Based on Bone Marrow Samples by the International MDS Working Group (IWG 2000) During Double-blind Period

The IWG criteria for bone marrow improvement: a complete remission is bone marrow sampling showing less than 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia. A partial remission is ≥ 50% decrease in blasts over pre-treatment. Bone marrow progression is a ≥ 50% increase in blasts that exceed the top range of the pretreatment percentile range: a) <5% blasts b) 5-10% blasts c) 10-20% blasts d) 20-30% blasts. For example, a participant with <5% blasts pretreatment with an on study blast increase of 50% which is now >5% showed bone marrow progression. (NCT00179621)
Timeframe: up to 52 weeks

Participants' Response in Absolute Neutrophil Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period

A major neutrophil response is defined by the International MDS Working Group (IWG) criteria as at least a 100% increase, or an absolute increase of ≥500/mm^3 for participants with absolute neutrophil counts (ANC) of less than 1,500/mm^3 before therapy, whichever is greater. A minor response for such participants is defined as an ANC increase of at least 100%, but absolute increase <500/mm^3. (NCT00179621)
Timeframe: up to week 52

Participants' Response in Platelet Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period

The International MDS Working Group (IWG) defines a major platelet response for participants with a pre-treatment platelet count of <100,000/mm^3 as an absolute increase of ≥30,000/mm^3 whereas a minor response is defined as a ≥50% increase in platelet count with a net increase greater than 10,000/mm^3 but less than 30,000/mm^3. (NCT00179621)
Timeframe: up to 52 weeks

Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period

"Counts of study participants who had adverse events (AEs) during the double-blind period by MedDRA System Organ Class (SOC) and preferred term. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.~The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE." (NCT00179621)
Timeframe: up to week 52

Kaplan Meier Estimate for Overall Survival

Overall survival was measured from the start of therapy in CC-5013-MDS-003 to the date of death from any cause. Results include data collected during the extension follow-up. (NCT01099267)
Timeframe: up to 7 years

Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)

Progression to AML was measured from the start of therapy in CC-5013-MDS-003 to the date AML was diagnosed. Results include data collected during the extension follow-up. (NCT01099267)
Timeframe: up to 7 years

Cause of Death for Participants Who Died

Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up. (NCT01099267)
Timeframe: up to 7 years

Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up

Count of participants who progressed to AML at the time of the extension study follow-up. (NCT01099267)
Timeframe: up to 7 years

Participants Survival Status as of the Time of the Extension Study Follow-up

Count of participants who were alive or deceased at the time of the extension study follow-up. (NCT01099267)
Timeframe: up to 7 years

Complete Response

Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. (NCT00352365)
Timeframe: Up to 5 years

Cytogenetic Abnormalities

Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders. (NCT00352365)
Timeframe: Up to 5 years

Total Response

Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Partial remission (PR): ANC >1,000/mcl, platelet count >100,000/mcl, and at least 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods. (NCT00352365)
Timeframe: Up to 5 years

Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

Only adverse events that are possibly, probably or definitely related to study drug are reported. (NCT00352365)
Timeframe: Up to 5 years

Evaluation of Stringent Complete Response, Complete Response, and Very Good Partial Response Rate (sCR + CR + VGPR Rate).

Assessed by the investigator per International Myeloma Working Group criteria(IMWG) uniform response criteria. Result reflects number of participants whose best overall response qualified as sCR, CR, or VGPR in 2 year follow up period. (NCT02906332)
Timeframe: Every 3 weeks (day 1 of every 21-day treatment cycle +/- 7 days) through 12 weeks.

Number of Participants Serious Adverse Events

Safety will be assessed by quantifying the toxicities and grades experienced by subjects who have received pembrolizumab (MK-3475), lenalidomide and dexamethasone, including serious adverse events (SAEs). Result reflects count of participants who experienced an SAE. (NCT02906332)
Timeframe: Up to 3 years

Number of Participants Who Progressed at 12 Months

Assessed at 12 months; Subjects without documented PD or death will be censored at the last disease assessment date. Those who died without documented PD will be censored at the time of death. Result reflects count of participants who had progressed at 12 months. (NCT02906332)
Timeframe: Time from Day 0 (transplant) and date of enrollment to study completion (through 12 weeks) by investigator assessment.

Progression Free Survival (PFS)

PFS will be assessed from the date of ASCT, with day 0 defined as date of stem cell infusion (if tandem transplant the 2nd of 2 transplants will be used) until the date of progression, defined as the date at which the patient starts the next line of therapy or the date of death. (NCT02906332)
Timeframe: Up to 3 years

Number of Patients Who Relapsed After Transplant

(NCT02416206)
Timeframe: 3 years

Number of Patients With Overall Survival Post-transplant

(NCT02416206)
Timeframe: 3 years

Number of Patients With Progression-free Survival

(NCT02416206)
Timeframe: 3 years

Complete Response

Analysis of the Primary Endpoint: The complete responses will be estimated by the number of patients with CR divided by the total number of evaluable patients. (NCT01723839)
Timeframe: 28 day cycle, up to 4 cycles

Overall Response Rate

Analysis of the other Secondary Endpoints: The overall response rate will be estimated by the number of patients with complete and partial responses divided by the total number of evaluable patients. (NCT01723839)
Timeframe: 28 day cycle, up to 6 cycles

Change in Hemoglobin Concentration From Baseline to Maximum Value During Response Period for Responders

The change from baseline in hemoglobin for participants who became RBC-transfusion independent. The maximum hemoglobin value obtained during the response period is used in the calculation of change from baseline. (NCT00065156)
Timeframe: Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)

Kaplan Meier Estimate for Duration of Transfusion Independence Response

Duration of response is measured from the first of the consecutive 56 days during which the participant was free of RBC transfusions to the date of the first RBC transfusion after this period. Duration of response was censored at the date of last visit for participants who maintained transfusion independence. (NCT00065156)
Timeframe: up to 2 years

Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence

"Number of participants who achieved RBC-transfusion independence, which was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive rolling 56 days during the treatment period (eg, Days 1 to 56, Days 2 to 57, Days 3 to 58, etc), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin." (NCT00065156)
Timeframe: Up to 2 years

Participants With a >= 50% Decrease From Baseline in Red Blood Cell (RBC) Transfusion Requirements Over Any Consecutive 56 Days During Study

A participant was categorized as having a transfusion reduction response if there was a ≥ 50% decrease from pretreatment transfusion requirements (before the start of the study mediation) compared to any consecutive 56 days during the study (i.e. post treatment). (NCT00065156)
Timeframe: Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)

Time to Transfusion Independence

"Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive rolling 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Time to transfusion independence was defined as the day of the first dose of study drug to the first day of the first 56-day RBC transfusion-free period." (NCT00065156)
Timeframe: up to 2 years

Participant Counts of Absolute Neutrophil Count (ANC) Response

"Major neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3 in all values obtained within 56 days of start of treatment, a ≥ 100% increase or an absolute increase of~≥ 500/mm^3, whichever was greater (at least to be ≥ 500/mm^3), sustained for 56 consecutive days. Minor neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3, an increase in ANC concentration of ≥ 100% sustained for 56 consecutive days." (NCT00065156)
Timeframe: up to 2 years

Participant Counts of Cytogenetic Response

"Participants deemed evaluable by the central cytogenetic review had their cytogenetic response categorized as major or minor. A major cytogenetic response was defined as ≥ 20 metaphases recorded at baseline, and at least~1 post baseline evaluation with ≥ 20 metaphases analyzed with no abnormal metaphases observed. A minor cytogenetic response was defined as ≥ 20 metaphases analyzed at baseline, and at least 1 post baseline evaluation with ≥ 20 metaphases analyzed with a ≥ 50% reduction in the proportion of hematopoietic cells with cytogenetic abnormalities compared with baseline." (NCT00065156)
Timeframe: up to 2 years

Participant Counts of Platelet Response

"Major platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3 in all values within 56 days of start of treatment, an absolute increase of ≥30,000/mm^3 sustained for ≥56 consecutive days. In platelet transfusion-dependent participants, a major response was stabilization of platelet counts and platelet transfusion independence.~Minor platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3, a ≥ 50% increase in platelet count with a net increase >10,000/mm^3 for a consecutive 56-day period in the absence of platelet transfusions." (NCT00065156)
Timeframe: up to 2 years

Participants Who Relapsed or Maintained Their Transfusion Independence After Achieving Transfusion Independence During the Study

"Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive rolling 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Participants who relapsed required a transfusion after the period of transfusion independence. Participants who maintained transfusion independence did not require a transfusion during the remainder of the study." (NCT00065156)
Timeframe: up to 2 years

Participants With Adverse Experiences

"Counts of study participants who had adverse events (AEs) during the study. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.~The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE." (NCT00065156)
Timeframe: Up to 2 Years

Participants With Bone Marrow Progression

"Bone marrow aspirate was assessed by a central reviewer. Progression is represented in two categories according to changes from baseline in French-American-British (FAB) classification (see Baseline Characteristics):~Baseline classification of refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) to a during treatment (plus 30 days) classification of refractory anemia with excess blasts (RAEB).~Any baseline FAB classification to a during treatment (plus 30 days) classification of acute myeloid leukemia (AML)." (NCT00065156)
Timeframe: up to 2 years

Participants With Complete or Partial Bone Marrow Improvement

Bone marrow aspirates were assessed by a central reviewer. A complete bone marrow improvement required a baseline French-American-British (FAB) classification (see Baseline Characteristics) of refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) and a during study assessment of no MDS. A partial bone marrow improvement reflected an improved FAB classification compared to baseline (e.g. RARS to RA) but evidence of MDS continued to exist. (NCT00065156)
Timeframe: up to 2 years

Reviews

42 reviews available for thalidomide and Chromosome Deletion

Trials

29 trials available for thalidomide and Chromosome Deletion

Other Studies

123 other studies available for thalidomide and Chromosome Deletion