Multiple MyelomaPhase 2EMMA-1NCT00368121
EMMA-1 (Erbitux for Multiple Myeloma)
A Phase 2 study testing Cetuximab +/- Dexamethasone in people with Multiple Myeloma, run by Prof. Dr. Andreas Engert at 3 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Cetuximab +/- Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesGermany
- Study dates
- Aug 2006to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University of Cologne, Department I of Internal Medicine
Cologne, 50931
Universtiy Hospital of Muenster, Internal Medicine A
Münster, 48129
University of Würzburg
Würzburg
About this study
Official title: Phase II Study of Cetuximab for the Refractory or Relapsed Multiple Myeloma EMMA-1(Erbitux for Multiple Myeloma)
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
- Multiple Myeloma
- Being tested
- Cetuximab +/- Dexamethasone
- Keywords
- Multiple Myeloma, Cetuximab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab +/- DexamethasoneDrug
Also called Erbitux
Cetuximab dosing schedule:
- Loading dose of 400 mg/m2, followed by weekly doses of 250 mg/m2. Cetuximab will be administered once weekly over 16 weeks. Mode of administration: intravenous infusion
Dexamethasone dosing schedule:
- 20 mg administered on day 1-3, q1w, starting week 5 if evidence of tumor progression or week 9 if no PR or CR to Cetuximab alone.
Mode of administration: orally
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab + Dexamethasone | Experimental | Not described Receives: Drug: Cetuximab +/- Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months)
Measured: After 16 weeks
Secondary outcomes (5)
Safety profile of Cetuximab +/- Dexamethasone
Measured: During 16 weeks of intervention and 8 weeks after
Freedom from treatment failure
Measured: 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.
Progression-free survival
Measured: from the date of registration until first documentation of progression/relapse of disease or death related to MM
Overall survival
Measured: From the date of registration until the date of death from any cause or (if the patients is alive) until the date of last information.
Pharmacogenomic evaluation of response to treatment
Measured: After 16 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Lack of recruitable patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Andreas Engert
- Sponsor type
- University, hospital or other
- Collaborators
- The Clinical Trials Centre Cologne
- Responsible party
- Sponsor-investigator, Prof. Dr. Andreas Engert, University of Cologne
- Investigators
- Andreas Engert, Prof. MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368121
- Sponsor's protocol ID
- EMMA-1
- Acronym
- EMMA-1
- Status last verified
- Jul 2012
- First submitted
- 23 Aug 2006
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Cetuximab for the Refractory or Relapsed Multiple Myeloma EMMA-1(Erbitux for Multiple Myeloma)
- ClinicalTrials.gov ID
- NCT00368121
- Acronym / sponsor ID
- EMMA-1 / EMMA-1
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Cetuximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitable patients
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Prof. Dr. Andreas EngertUniversity, hospital or other
- Collaborators
- The Clinical Trials Centre Cologne
- Study start
- Aug 2006
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab + Dexamethasone | Experimental | Drug: Cetuximab +/- Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetuximab +/- DexamethasoneAlso: ErbituxCetuximab dosing schedule: • Loading dose of 400 mg/m2, followed by weekly doses of 250 mg/m2. Cetuximab will be administered once weekly over 16 weeks. Mode of administration: intravenous infusion Dexamethasone dosing schedule: • 20 mg administered on day 1-3, q1w, starting week 5 if evidence of tumor progression or week 9 if no PR or CR to Cetuximab alone. Mode of administration: orally | Drug | Cetuximab + Dexamethasone |
Primary outcome
Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months)
Time frame: After 16 weeks
5 secondary outcomes
Safety profile of Cetuximab +/- Dexamethasone
Time frame: During 16 weeks of intervention and 8 weeks after
Freedom from treatment failure
Time frame: 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.
Progression-free survival
Time frame: from the date of registration until first documentation of progression/relapse of disease or death related to MM
Overall survival
Time frame: From the date of registration until the date of death from any cause or (if the patients is alive) until the date of last information.
Pharmacogenomic evaluation of response to treatment
Time frame: After 16 weeks of intervention
Results and safety
The study was stopped early (reason given: Lack of recruitable patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
Related trials for Multiple Myeloma
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
RecruitingObservational study
The Indiana Myeloma Registry
Plasma Cell Dyscrasias
RecruitingPhase 2
A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.
Multiple Myeloma, Refractory
RecruitingPhase 2
18F-Fluciclovine PET/CT in Multiple Myeloma
Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM)
Active, not recruitingObservational study
Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Engert, Prof. MD principal investigator
University of Cologne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab +/- Dexamethasone in people with Multiple Myeloma, run by Prof. Dr. Andreas Engert at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitable patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months) (time frame: After 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2012; AzTrials last refreshed its copy on 30 Oct 2026.