thalidomide and Heart Diseases

thalidomide has been researched along with Heart Diseases in 14 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Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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.

Heart Diseases: Pathological conditions involving the HEART including its structural and functional abnormalities.

Research

Studies (14)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Duration of Response

Assessed as the median value for the time from first partial response until progression; death; or last follow-up. (NCT00890552)
Timeframe: 32 months

Event-free Survival (EFS)

Assessed as the median value for EFS 12 months after starting MDR treatment (NCT00890552)
Timeframe: 12 months

Overall Survival (OS)

Participants alive 12 months after starting MDR treatment. (NCT00890552)
Timeframe: 12 months

Hematologic Response Rate

At the end of each treatment cycle (4 weeks), hematologic response rate as assessed. Hematologic response was considered to be amyloid complete response (normal FLC ratio and negative serum and urine immunofixation); very good partial response (difference between involved and uninvolved FLCs [dFLC] < 40 mg/L); or partial response (dFLC decrease > 50%). (NCT00890552)
Timeframe: 8 weeks

Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)

"Response that was confirmed on 2 consecutive evaluations during treatment.~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels." (NCT00564889)
Timeframe: Duration on study (up to 3 years)

Number of Participants With Severe Adverse Events

Severe adverse events were defined as grade 3 or higher, at least possibly related to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. (NCT00564889)
Timeframe: Duration of study (up to 3 years)

Number of Patients With Organ Response

"Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid.~Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of >= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by >= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either >= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to < 50% of previous movements/day, or decrease in fecal fat excretion by 50%." (NCT00564889)
Timeframe: Duration of study (up to 3 years)

Overall Survival (OS)

Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method. (NCT00564889)
Timeframe: Duration of study (up to 3 years)

Progression Free Survival (PFS)

Progression free survival (PFS) was defined as the time from registration to hematologic progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method. (NCT00564889)
Timeframe: Duration of study (up to 3 years)

Reviews

2 reviews available for thalidomide and Heart Diseases

Trials

4 trials available for thalidomide and Heart Diseases

Other Studies

8 other studies available for thalidomide and Heart Diseases