Clinical trial · Interventional
A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma
A Randomized, Open-Label, Multi-Center Trial Comparing Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Subjects With Newly Diagnosed Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| DOXIL | Drug | Doxorubicin | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Thalidomide + dexamethasone
- interventionNames
- Drug: Thalidomide
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- Thalidomide + dexamethasone + DOXIL
- interventionNames
- Drug: Thalidomide
- Drug: Dexamethasone
- Drug: DOXIL
Primary outcomes (1)
- measure
- Complete Response Rate: Number of Participants Who Achieved a Complete Response
- timeFrame
- From Cycle 2 until 28 days following completion of treatment
- description
- Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated, histologically confirmed multiple myeloma (per International Myeloma Working Group \[IMWG\] criteria * Eastern Cooperative Oncology Group (ECOG) status 0-2 * Adequate absolute neutrophil count (ANC), platelet count and hemoglobin * Adequate serum calcium * Enrollment in System for Thalidomide Education and Prescribing Safety Program (S.T.E.P.S.) Exclusion Criteria: * No treatment with dexamethasone for multiple myeloma * No peripheral neuropathy of Grade 2 or higher * No Left Ventricular Ejection Fraction (LVEF) of less than 45 percentage * No history of life-threatening thromboembolic events of any kind (ie, myocardial infarction, pulmonary embolism, stroke or others), within 1 year before enrollment in the study * No deep vein thrombosis (DVT) within 1 year of enrollment * No current anticoagulation for DVT
References
Publications (0)
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