Multiple MyelomaFIRST-NISNCT02537808
Non-interventional Study of Lenalidomide / Dexamethasone as First Line Therapy in Patients With Multiple Myeloma
An observational study of Multiple Myeloma, run by iOMEDICO AG at 1 site in Germany.
Trial summary
The objective of this non-interventional study is to explore the safety, effectiveness and quality of life of lenalidomide / dexamethasone as first line treatment for transplant-ineligible patients with multiple myeloma in a real life setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 172 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jun 2015to 13 Sep 2023
- Phase
- Observational
- 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
Study population: Transplant-ineligible patients with previously untreated, symptomatic multiple myeloma (as defined by IMWG criteria) and with an indication for medical treatment as assessed by the investigator.
Who may be able to join
- Diagnosis of multiple myeloma (2008 WHO classification) requiring treatment (as defined by IMWG)
- Indication for treatment as assessed by the treating physician
- Decision for first line combination therapy with lenalidomide and low-dose dexamethasone
- No previous systemic therapy for multiple myeloma
- Ineligibility for transplantation
- Aged 18 years or older
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- Written informed consent signed
- The conditions of the risk management plan/pregnancy prevention program (refer to the SmPC Revlimid®) must be followed by female and male patients
- Other criteria according to the SmPC. Special warnings and precautions of the SmPC have to be considered by the treating physician
Who cannot join
- Pregnant or breast-feeding women
- Any objections or contraindications according to the SmPC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-interventional Study of Lenalidomide (Revlimid®) in Combination With Dexamethasone as First Line Therapy in Transplant-ineligible Patients With Multiple Myeloma
The objective of this non-interventional study is to explore the safety, effectiveness and quality of life of lenalidomide / dexamethasone as first line treatment for transplant-ineligible patients with multiple myeloma in a real life setting.
Read the detailed description
The introduction of new drugs that can be differently combined with conventional chemotherapy or low-dose dexamethasone has changed substantially the treatment paradigm for patients with multiple myeloma. A variety of treatment options is now available for elderly patients. To compare the efficacy and safety of continuous lenalidomide in combination with low-dose dexamethasone (Rd) until progression vs. Rd for 18 cycles/72 weeks (Rd18) vs. melphalan, prednisone and thalidomide (MPT) for 12 cycles/72 weeks a multicenter, open-label phase III study (MM-020/IFM 07-01, FIRST trial) was performed in transplant ineligible patients.
After market approval of lenalidomide for previously untreated transplant-ineligible patients with multiple myeloma, the purpose of the FIRST-NIS is to evaluate the safety, effectiveness and quality of life of lenalidomide in combination with dexamethasone as first line treatment of multiple myeloma in a real life setting.
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) rate at 24 months
Measured: 24 months
Secondary outcomes (10)
To assess Median Overall Survival (OS)
Measured: 84 month
To assess safety and tolerability via AE and SAE reporting
AE, SAE and ADR are documented in the eCRF and will be used for safety assessment.
Measured: 24 months
To assess Quality of Life (EORTC QLQ-C30 and MY20
QoL data will be collected at baseline, after 3, 6, 12, 18 and 24 months
Measured: 24 months
To assess duration of hospitalisation periods
To estimate hospital resource utilization by documenting how much time (days/weeks) patients spend in the hospital during their treatment period.
Measured: 24 months
Overall Response Rate
Measured: 24 months
Median Progression-free survival (PFS)
Measured: 84 months
Median Time to Progression (TTP)
Measured: 84 months
Median Time to Response (TTR)
Measured: 24 months
Duration of Response
Measured: 84 months
Reason for treatment discontinuation
Measured: 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study start23 Jun 2015
- Primary completionSep 2020
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Holger Nückel, Professor, Principal investigator, Hämatologisch-Onkologische Schwerpunktpraxis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537808
- Sponsor's protocol ID
- IOM-12315
- Acronym
- FIRST-NIS
- Status last verified
- Nov 2023
- First submitted
- 24 Aug 2015
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nuckel H, Behlendorf T, Schulz H, Schulze M, Schardt C, Medinger T, Koenigsmann M, Dechow T, Indorf M, Burkle D, Engelbertz V, Rauh J, Schmidt B, Sauer A, Vannier C, Potthoff K. Lenalidomide Plus Dexamethasone as FIRST-Line Therapy in Transplant-Ineligible Patients With Multiple Myeloma: Final Results of the Prospective, Non-Interventional Study FIRST-NIS and Comparison With the FIRST Pivotal Phase III Clinical Trial. Cancer Med. 2026 Apr;15(4):e71758. doi: 10.1002/cam4.71758.
PubMed 41927857
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study of Lenalidomide (Revlimid®) in Combination With Dexamethasone as First Line Therapy in Transplant-ineligible Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02537808
- Acronym / sponsor ID
- FIRST-NIS / IOM-12315
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2015 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 2 Sep 2015 (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.
The objective of this non-interventional study is to explore the safety, effectiveness and quality of life of lenalidomide / dexamethasone as first line treatment for transplant-ineligible patients with multiple myeloma in a real life setting.
Detailed description
The introduction of new drugs that can be differently combined with conventional chemotherapy or low-dose dexamethasone has changed substantially the treatment paradigm for patients with multiple myeloma. A variety of treatment options is now available for elderly patients. To compare the efficacy and safety of continuous lenalidomide in combination with low-dose dexamethasone (Rd) until progression vs. Rd for 18 cycles/72 weeks (Rd18) vs. melphalan, prednisone and thalidomide (MPT) for 12 cycles/72 weeks a multicenter, open-label phase III study (MM-020/IFM 07-01, FIRST trial) was performed in transplant ineligible patients.
After market approval of lenalidomide for previously untreated transplant-ineligible patients with multiple myeloma, the purpose of the FIRST-NIS is to evaluate the safety, effectiveness and quality of life of lenalidomide in combination with dexamethasone as first line treatment of multiple myeloma in a real life setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Transplant-ineligible patients with previously untreated, symptomatic multiple myeloma (as defined by IMWG criteria) and with an indication for medical treatment as assessed by the investigator.
Key inclusion criteria (9 listed)
- Diagnosis of multiple myeloma (2008 WHO classification) requiring treatment (as defined by IMWG)
- Indication for treatment as assessed by the treating physician
- Decision for first line combination therapy with lenalidomide and low-dose dexamethasone
- No previous systemic therapy for multiple myeloma
- Ineligibility for transplantation
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding women
- Any objections or contraindications according to the SmPC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival (PFS) rate at 24 months
Time frame: 24 months
10 secondary outcomes
To assess Median Overall Survival (OS)
Time frame: 84 month
To assess safety and tolerability via AE and SAE reporting
Time frame: 24 months
To assess Quality of Life (EORTC QLQ-C30 and MY20
Time frame: 24 months
To assess duration of hospitalisation periods
Time frame: 24 months
Overall Response Rate
Time frame: 24 months
Median Progression-free survival (PFS)
Time frame: 84 months
Median Time to Progression (TTP)
Time frame: 84 months
Median Time to Response (TTR)
Time frame: 24 months
Duration of Response
Time frame: 84 months
Reason for treatment discontinuation
Time frame: 84 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 41927857Nuckel H, Behlendorf T, Schulz H, Schulze M, Schardt C, Medinger T, Koenigsmann M, Dechow T, Indorf M, Burkle D, Engelbertz V, Rauh J, Schmidt B, Sauer A, Vannier C, Potthoff K. Lenalidomide Plus Dexamethasone as FIRST-Line Therapy in Transplant-Ineligible Patients With Multiple Myeloma: Final Results of the Prospective, Non-Interventional Study FIRST-NIS and Comparison With the FIRST Pivotal Phase III Clinical Trial. Cancer Med. 2026 Apr;15(4):e71758. doi: 10.1002/cam4.71758.
- Individual participant dataSharing planned: No
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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.
Holger Nückel, Professor principal investigator
Hämatologisch-Onkologische Schwerpunktpraxis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by iOMEDICO AG at 1 site 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 2 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression-free survival (PFS) rate at 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02537808, which also lists 1 linked publication.
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 18 Nov 2023; AzTrials last refreshed its copy on 3 Nov 2026.