Multiple MyelomaPhase 3NCT01621672
UARK 2009-09 Myeloma Cure Project: Prospective Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma
A Phase 3 study testing Revlimid in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to determine in a phase II trial, whether further maintenance therapy with Revlimid can extend the duration of progression-free survival and the duration of complete or near complete response compared to no further therapy beyond the TT3 protocol-prescribed 3 years of maintenance with 1… 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?
- Revlimid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Aug 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male and female participants of all races/ethnicities with multiple myeloma previously enrolled on UARK 2003-33 or 2006-66.
- Participant has completed 3 years of maintenance therapy with one of the three study drugs of VTD or VRD and disease status has remained event free (includes patients who prematurely discontinued maintenance therapy as long as 3 years have elapsed since beginning of maintenance).
- All patients must be ages 18 years of age or greater at the time of signing the informed consent form.
- Participant has adequate hematopoietic reserve, defined as platelets > 50,000/μL (in participants with bone marrow hypoplasia, remaining peripheral blood progenitor cells can be infused to boost hematopoietic reserve prior to enrollment).
- Participant has adequate renal function defined as serum creatinine < 3 mg/dL prior to enrolling on study
- Total bilirubin ≤ 1.5 mg/dL prior to enrolling on study
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- AST (SGOT) and ALT (SGPT) ≤ 2 x ULN prior to enrolling on study
- Patient must have signed an IRB-approved informed consent and understand the investigational nature of the study.
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®
- Pregnant or nursing women may not participate. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within
- 24 hours of prescribing Revlimid® (lenalidomide; prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking Revlimid® (lenalidomide).
- FCBP must also agree to ongoing pregnancy testing.
- Lactating females must agree that they will not breastfeed.
- Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure,
- Pregnancy Testing Guidelines and Acceptable Birth Control Methods † A female of childbearing potential is a sexually mature woman who:
- has not undergone a hysterectomy or bilateral oophorectomy
- has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Who cannot join
- Any condition that the PI believes, laboratory abnormality, or psychiatric illness that would prevent the subject from being enrolled in the research study.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking Revlimid®)
- Any condition, including the presence of laboratory abnormalities, 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.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis, type B or C.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Science-MIRT
Little Rock, Arkansas, 72205
About this study
Official title: Myeloma Cure Project: Prospective, Randomized Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma Who Have Completed 3 Years of VTD/TD or VTD or VRD Maintenance on Total Therapy 3 (TT3) Trials 2003-33 and 2006-66
The purpose of this study is to determine in a phase II trial, whether further maintenance therapy with Revlimid can extend the duration of progression-free survival and the duration of complete or near complete response compared to no further therapy beyond the TT3 protocol-prescribed 3 years of maintenance with 1 year of VTD plus 2 years with TD, 3 years with VTD (2003-33) or VRD (2006-66).
Read the detailed description
Determine the associated toxicities in qualitative and quantitative terms using NCI CTCAE(NCI common terminology for adverse events)
- Conditions
- Multiple Myeloma
- Being tested
- Revlimid
- Keywords
- Revlimid, progression free, Lenalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevlimidDrug
Also called Lenalidomide
10 mg/day in the morning same time each day
| Study group | Role | What they receive |
|---|---|---|
| Revlimid | Experimental | Revlimid dosing will be in the morning at the same time each day Receives: Drug: Revlimid |
| No further treatment | No intervention | No treatment control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression was defined as any one or more of the following:
- Serum M protein increase ≥ 25% from baseline (or an increase of ≥ 1 g/dL if serum M protein was ≥ 5 g/dL at baseline), with an absolute increase of ≥ 0.5 g/dL; or
- Urine M protein increase ≥ 25% from baseline, with an absolute increase of ≥ 200 mg/24 hrs; or
- If patient had serum M protein < 1 g/dL, urine M protein < 200 mg/24 hrs, and an involved serum free light chain level ≥ 10 mg/dL at baseline: ≥ 25% increase in the difference between involved and uninvolved serum free light chain level, with an absolute increase of ≥ 10 mg/dL; or
- Bone marrow plasma cell percentage increase ≥ 25% from baseline, with the absolute plasma cell % ≥ 10%; or
- New bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas; or
- Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to multiple myeloma.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startApr 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bart Barlogie, MD, PhD, Principal investigator, UAMS Myeloma Institute for Research & Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621672
- Sponsor's protocol ID
- 110468
- Status last verified
- Sep 2015
- First submitted
- 31 May 2012
- Last updated
- 19 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloma Cure Project: Prospective, Randomized Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma Who Have Completed 3 Years of VTD/TD or VTD or VRD Maintenance on Total Therapy 3 (TT3) Trials 2003-33 and 2006-66
- ClinicalTrials.gov ID
- NCT01621672
- Acronym / sponsor ID
- 110468
- Conditions
- Multiple Myeloma
- Keywords
- Revlimid, progression free, Lenalidomide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Posted 10 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine in a phase II trial, whether further maintenance therapy with Revlimid can extend the duration of progression-free survival and the duration of complete or near complete response compared to no further therapy beyond the TT3 protocol-prescribed 3 years of maintenance with 1 year of VTD plus 2 years with TD, 3 years with VTD (2003-33) or VRD (2006-66).
Detailed description
Determine the associated toxicities in qualitative and quantitative terms using NCI CTCAE(NCI common terminology for adverse events)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revlimid | Experimental | Drug: RevlimidRevlimid dosing will be in the morning at the same time each day |
| No further treatment | No intervention | –No treatment control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male and female participants of all races/ethnicities with multiple myeloma previously enrolled on UARK 2003-33 or 2006-66.
- Participant has completed 3 years of maintenance therapy with one of the three study drugs of VTD or VRD and disease status has remained event free (includes patients who prematurely discontinued maintenance therapy as long as 3 years have elapsed since beginning of maintenance).
- All patients must be ages 18 years of age or greater at the time of signing the informed consent form.
- Participant has adequate hematopoietic reserve, defined as platelets > 50,000/μL (in participants with bone marrow hypoplasia, remaining peripheral blood progenitor cells can be infused to boost hematopoietic reserve prior to enrollment).
- Participant has adequate renal function defined as serum creatinine < 3 mg/dL prior to enrolling on study
Key exclusion criteria (8 listed)
- Any condition that the PI believes, laboratory abnormality, or psychiatric illness that would prevent the subject from being enrolled in the research study.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking Revlimid®)
- Any condition, including the presence of laboratory abnormalities, 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.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
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 |
|---|---|---|
| RevlimidAlso: Lenalidomide10 mg/day in the morning same time each day | Drug | Revlimid |
Primary outcome
Progression Free Survival (PFS)
Time frame: 2 years
Progression was defined as any one or more of the following: * Serum M protein increase ≥ 25% from baseline (or an increase of ≥ 1 g/dL if serum M protein was ≥ 5 g/dL at baseline), with an absolute increase of ≥ 0.5 g/dL; or * Urine M protein increase ≥ 25% from baseline, with an absolute increase of ≥ 200 mg/24 hrs; or * If patient had serum M protein < 1 g/dL, urine M protein < 200 mg/24 hrs, and an involved serum free light chain level ≥ 10 mg/dL at baseline: ≥ 25% increase in the difference between involved and uninvolved serum free light chain level, with an absolute increase of ≥ 10 mg/dL; or * Bone marrow plasma cell percentage increase ≥ 25% from baseline, with the absolute plasma cell % ≥ 10%; or * New bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas; or * Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to multiple myeloma.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bart Barlogie, MD, PhD principal investigator
UAMS Myeloma Institute for Research & Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Revlimid in people with Multiple Myeloma, run by University of Arkansas 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 17 inclusion and 8 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 19 Oct 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) (time frame: 2 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 19 Oct 2015.