Clinical trial · Interventional
Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma
Clarithromycin Plus CTd (Cyclophosphamide,Thalidomide and Dexamethasone)Regimen for Patients With Newly Diagnosed Multiple Myeloma:a Phase 3 , Multicenter,Randomized, Open-Label Trial.
- 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)
Due to economic reasons, thalidomide is still widely used as a first line drug for Multiple Myeloma patients in China. However,the efficacy of CTd is still lower than the therapeutic regimens with new drugs. Clarithromycin may have partly efficacy in association with steroids and thalidomide for Multiple Myeloma patients. This multicenter, randomized, phase 3 clinical trial is proposed to explore whether clarithromycin could potentiate responsiveness of CTd (Cyclophosphamide, Thalidomide and Dexamethasone) regimen in Newly Diagnosed Multiple Myeloma patients. The trial will also evaluate the side effects caused by the combination of these drugs.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clarithromycin | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BiCTd regimen
- description
- Induction and consolidation therapy: BiCTd regimen for 8 cycles. Patients received Clarithromycin 500 mg orally on days 1-28,thalidomide 100-200mg orally on days d1-28, dexamethasone 40mg orally on days on 1,8,15,22, and cyclophosphamide 300mg/m\^2 intravenously on day 1-3. Cycles were repeated every 28 days. Maintenance therapy:CP regimen (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,repeated every 28 days) until disease progression. If efficacy \<PR after 4 cycles of induction or disease progression at anytime，patients will be quitted.
- interventionNames
- Drug: Clarithromycin
- Drug: Thalidomide
- Drug: Cyclophosphamide
- Drug: Dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- CTd regimen
- description
- Induction and consolidation therapy: CTd regimen for 8 cycles. Patients received thalidomide 100-200mg orally on days d1-28, dexamethasone 40 mg orally on days on 1,8,15,22, and cyclophosphamide 300 mg/m\^2 intravenously on day 1-3. Cycles were repeated every 28 days. Maintenance therapy:CP regimen (cyclophosphamide 200 mg orally on days 1-14 and prednisone 30mg twice daily orally on days 1-7,28 Days per Cycle) until disease progression. If efficacy \<PR after 4 cycles of induction or disease progression at anytime，patients will be quitted. If no further reduction in the serum and urine M protein in the next cycle，patients may cross over to BiCTd regimen.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent form * Able to adhere to the study visit schedule and other protocol requirements * Diagnosed with active multiple myeloma * Previously untreated * Karnofsky performance status(KPS) ≥50（KPS\<50 will be allowed if related to bony disease） * New York Heart Association(NYHA) functional ≤class III Exclusion Criteria: * Hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics; * Concomitant administration of cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin, lovastatin, and atorvastatin; * A history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin. * Impaired renal function,Creatinine ≥221umol/L； * Pregnant or breast feeding females. * Any condition which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
References
Publications (0)
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