Clinical trial · Interventional
EMMA-1 (Erbitux for Multiple Myeloma)
Phase II Study of Cetuximab for the Refractory or Relapsed Multiple Myeloma EMMA-1(Erbitux for Multiple Myeloma)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of recruitable patients
Summary
Brief summary (as posted)
EMMA-1 is an open-label, non-randomized, two-stage phase II study. Patients with refractory multiple myeloma stage II or III or relapsed disease after at least one line of treatment will receive Cetuximab+/-Dexamethasone. The planed treatment duration per patient is 16 weeks. Patients achieving a response or stable disease after 16 weeks of treatment may continue study medication for 6 more months (patients receiving Cetuximab alone) or for 3 more months (patients receiving Cetuximab plus Dexamethasone). Responding patients who relapse during follow-up period of two years may receive a second treatment with Cetuximab following initial study guidelines
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab +/- Dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab + Dexamethasone
- interventionNames
- Drug: Cetuximab +/- Dexamethasone
Primary outcomes (1)
- measure
- Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months)
- timeFrame
- After 16 weeks
Secondary outcomes (5)
- measure
- Safety profile of Cetuximab +/- Dexamethasone
- timeFrame
- During 16 weeks of intervention and 8 weeks after
- measure
- Freedom from treatment failure
- timeFrame
- From the date of registration until the first event or (if none occurs) until the date of the last determination of continuing complete/partial remission.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Multiple myeloma diagnosed according to the Durie-criteria in stage II or III (Salmon and Durie) * Measurable disease * Refractory or relapsed disease after at least one line of treatment * Male or female \>= 18 years of age * Life expectancy \> 12 weeks * ECOG performances status 0-2 * If of childbearing potential, willingness to use effective contraceptive method for the study duration and 6 months post-dosing. * No surgery, radiotherapy or chemotherapy or any investigational agent within 30 days of study entry * Signed written informed consent Exclusion Criteria: * Asecretory multiple myeloma * Patients eligible and willing to undergo high dose chemotherapy followed by autologous stem cell transplantation * Prior allogeneic transplantation * Prior antibody or EGFR-pathway targeting therapy * Severe cardiovascular disease like functionally restricting heart rhythm disturbance or heart malformation or severe hypertension, or cardiac insufficiency \> NYHA-II * HIV Infection, Hepatitis B or C * Brain disorders, psychiatric illness * Insufficient bone marrow reserve (Leucocytes \< 1500/µl; Thrombocytes \< 50000/µl) * Creatinine-Clearance \< 30 ml/min or Crea \> 3.0 mg/dl * Bilirubin \> 2 mg/dl; ASAT, ALAT \> 100 U/l * Pregnancy (absence confirmed by serum/urine beta-HCG) or breast-feeding * FEV1 \< 50% of the reference value * Active secondary malignancy * Legal incapacity or limited legal capacity * Having participated in another clinical trial or any investigational agent in the preceding 30 days * Known allergic/hypersensitivity reaction to any compounds of the treatment * Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent * Known drug abuse/alcohol abuse
References
Publications (0)
Data not yet available