Clinical trial · Interventional
A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma
A Multicenter, Randomized, Parallel-group , Double Blind, Placebo-controlled Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone as Induction Therapy for Previously Untreated Subjects With 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)
To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A (Thalidomide + Dexamethasone) | Drug | — | UNRESOLVED |
| B (Placebo + Dexamethasone) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A (Thalidomide & Dexamethasone)
- description
- Thalidomide 50mg/day + Dexamethasone 40mg
- interventionNames
- Drug: A (Thalidomide + Dexamethasone)
- type
- PLACEBO_COMPARATOR
- label
- B (Dexamethasone and placebo)
- description
- Dexamethasone and placebo
- interventionNames
- Drug: B (Placebo + Dexamethasone)
Primary outcomes (1)
- measure
- Time to tumor progression (TTP)
- timeFrame
- Up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Active Multiple Myeloma Stage II or III Durie Salmon * Measurable levels of myeloma paraprotein in serum (≥1.0g/dL) or urine (≥ 0.2g excreted in a 24-hour collection sample) * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 * Women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective (for example hormonal or tubal ligation) and one barrier (for example latex condom, diaphragm) * Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity Exclusion Criteria: * Pregnant or lactating females * Peripheral neuropathy ≥ to grade 2 of the NCI CTC. * Prior history of malignancy unless subject has been free of disease for ≥ 3 years * Lab abnormality: Absolute neutrophil count (ANC) \<1,000 cells/mm\^3 (1.0 x 10\^9/L) * Lab abnormality: Platelet count \<50,000/mm\^3 (50.0 x 10\^9/L) * Lab abnormality: Serum creatinine \>3.0 mg/dL (265 µmol/L) * Lab abnormality: Serum glutamic oxaloacetic transaminase (SGOT) /Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine transaminase (ALT) \>3.0 x upper limit of normal (ULN) * Lab abnormality: Serum total bilirubin \> 2.0 mg/dL (34 µmol/L)
References
Publications (1)
- RESULTRajkumar SV, Rosinol L, Hussein M, Catalano J, Jedrzejczak W, Lucy L, Olesnyckyj M, Yu Z, Knight R, Zeldis JB, Blade J. Multicenter, randomized, double-blind, placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initial therapy for newly diagnosed multiple myeloma. J Clin Oncol. 2008 May 1;26(13):2171-7. doi: 10.1200/JCO.2007.14.1853. Epub 2008 Mar 24. PMID 18362366