Multiple MyelomaPhase 2AMM-2011NCT01617213
Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma
A Phase 2 study testing Melphalan and Lenalidomide in people with Multiple Myeloma, run by University of Virginia at 1 site in United States.
Trial summary
This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2) with autologous PBSC transplant. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Melphalan and Lenalidomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 to 75 years of age.
- ECOG performance status of 0, 1 or 2.
- Patients who have a history of another malignant disorder are eligible, provided that they have not received active therapy for 5 years. Patients with basal cell and squamous cell skin cancers are eligible.
- Patients who are pregnant are ineligible.
- Patients must furnish written informed consent and HIPAA authorization for release of personal health information.
- Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments.
- Patients must be HIV and HTLV-I,-II antibody sero-negative.
- Patients must have adequate visceral organ function
Who cannot join
- Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, or a cumulative anthracycline exposure in excess of 550 mg/m2 Adriamycin (doxorubicin) unless the gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.
- Patients are ineligible if they are receiving any other investigational agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma
This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2) with autologous PBSC transplant.
- Conditions
- Multiple Myeloma
- Being tested
- Melphalan, Lenalidomide
- Keywords
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelphalanDrug
200 mg/m2/IV
LenalidomideDrug
10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Lenalidomide After Melphalan | Experimental | Not described Receives: Drug: Melphalan; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival
Duration of time until patient experiences an event (recurrence, relapse or death)
Measured: 3 years
Secondary outcomes (5)
Disease Response
Number of patients that have complete and very good partial responses.
Measured: 2 years
Overall survival
Duration of time from Day 0 until death.
Measured: 4 years
Grade > 2 toxicities
Percent of patients experiencing one or more toxicity greater than 2.
Measured: 4 years
Incidence of infections
Percent of patients experiencing a definite or probable viral, fungal or bacterial infection.
Measured: 4 years
Treatment related Mortality
Number of patients that experience a death from causes other relapse or progression.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2015 (estimated)
Why it stopped: Study is no longer needed as recent data have answered the primary hypotheses for this study.
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.
- More trials run by University of VirginiaThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Laughlin, MD, University of Virginia
- Investigators
- Mary J. Laughlin, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617213
- Sponsor's protocol ID
- 16043
- Acronym
- AMM-2011
- Status last verified
- Jun 2013
- First submitted
- 8 Jun 2012
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01617213
- Acronym / sponsor ID
- AMM-2011 / 16043
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study is no longer needed as recent data have answered the primary hypotheses for this study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2015 (estimated)
- First posted
- 12 Jun 2012 (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.
This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2) with autologous PBSC transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance Lenalidomide After Melphalan | Experimental | Drug: Melphalan, Drug: Lenalidomide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be 18 to 75 years of age.
- ECOG performance status of 0, 1 or 2.
- Patients who have a history of another malignant disorder are eligible, provided that they have not received active therapy for 5 years. Patients with basal cell and squamous cell skin cancers are eligible.
- Patients who are pregnant are ineligible.
- Patients must furnish written informed consent and HIPAA authorization for release of personal health information.
Key exclusion criteria (2 listed)
- Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, or a cumulative anthracycline exposure in excess of 550 mg/m2 Adriamycin (doxorubicin) unless the gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.
- Patients are ineligible if they are receiving any other investigational agents.
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 |
|---|---|---|
| Melphalan200 mg/m2/IV | Drug | Maintenance Lenalidomide After Melphalan |
| Lenalidomide10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug. | Drug | Maintenance Lenalidomide After Melphalan |
Primary outcome
Event Free Survival
Time frame: 3 years
Duration of time until patient experiences an event (recurrence, relapse or death)
5 secondary outcomes
Disease Response
Time frame: 2 years
Overall survival
Time frame: 4 years
Grade > 2 toxicities
Time frame: 4 years
Incidence of infections
Time frame: 4 years
Treatment related Mortality
Time frame: 4 years
Results and safety
The study was stopped early (reason given: Study is no longer needed as recent data have answered the primary hypotheses for this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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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.
Mary J. Laughlin, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melphalan and Lenalidomide in people with Multiple Myeloma, run by University of Virginia at 1 site in United States.
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 8 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: stopped early, as of the sponsor's last update on 21 Jun 2013. 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 United States. 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: Study is no longer needed as recent data have answered the primary hypotheses for this study.). 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?
Event Free Survival (time frame: 3 years). 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 21 Jun 2013.