Multiple MyelomaPhase 2NCT00540644
Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma
A Phase 2 study testing lenalidomide (Revlimid®), Cyclophosphamide and Prednisone in people with Multiple Myeloma, run by Attaya Suvannasankha at 1 site in United States.
Trial summary
The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma. 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?
- lenalidomide (Revlimid®), Cyclophosphamide and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Aug 2014
- Phase
- Phase 2
- 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
- Patients with newly diagnosed, symptomatic multiple myeloma based on the following criteria:
- Presence of an M-component in serum and/or urine plus clonal plasma cells in the bone marrow and/or a documented clonal plasmacytoma
- PLUS one or more of the following:
- Calcium elevation (11.5 mg/dl) [42.65 mmol/l]
- Renal insufficiency (1.5 x the ULN of serum creatinine)
- Anemia (hemoglobin <=10 g/dl or 2 g/dl <= normal)
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- Bone disease (lytic lesions or osteopenia)
- Measurable disease is defined at least one of the following three measurements:
- Serum M-protein >=1 g/dl ( or 10 g/l)
- Urine M-protein >=200 mg/24 h
- Serum FLC assay: Involved FLC level >=10 mg/dl (>=100 mg/l) provided serum FLC ratio is abnormal
- Measurable plasmacytoma
- NOTE: If a patient meets the criteria for symptomatic multiple myeloma but does not meet serum M-protein, urine M-protein or serum FLC levels stated above, percent plasma cells in bone marrow will be used to follow response.
- Laboratory test results within these ranges:
- Absolute neutrophil count >= 1.0 x 109/L
- Platelet count >= 50 x 10(9)/L
- Hemoglobin >= 9 gm/dl
- Serum creatinine <= 2.5mg/dL.
- Total bilirubin <=1.5 x upper limit of normal
- AST (SGOT) and ALT (SGPT) <= 3 x ULN
Who cannot join
- Known hypersensitivity to thalidomide
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Patients with a solitary plasmacytoma
- Patients with uncontrolled diabetes
- Patients with ≥ Grade 3 sensory neuropathy
- History of cardiac disease, with NYHA Class II or greater
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma
The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.
Read the detailed description
This is a phase II single institution trial in patients with newly diagnosed multiple myeloma. Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D..
- Conditions
- Multiple Myeloma
- Being tested
- lenalidomide (Revlimid®), Cyclophosphamide, Prednisone
- Keywords
- Multiple Myeloma, Revlimid
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomide (Revlimid®)Drug
Also called Revlimid®
25 mg p.o. daily on days 1-21 of each 28 day cycle
CyclophosphamideDrug
50 mg p.o. BID daily on days 1-21 of each 28 day cycle
PrednisoneDrug
50 mg p.o. Q.O.D.
| Study group | Role | What they receive |
|---|---|---|
| Revlimid, Cyclophosphamide, Prednisone | Experimental | Lenalidomide orally on Days 1-21 followed by 7 days rest, repeated every 28 days.
Cyclophosphamide twice daily, orally on Days 1-21 followed by 7 days rest, repeated every 28 days.
Prednisone every other day orally. Receives: Drug: lenalidomide (Revlimid®); Drug: Cyclophosphamide; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.
Measured: After 6 cycles
Secondary outcomes (2)
Treatment Related Adverse Events Grade 3 or Higher
Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.
Measured: Beginning of treatment up to 5 years
Quality of Life Using the FACT-G Data
Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.
Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome
Measured: baseline and after last cycle (up to 6 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2012
- 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.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attaya Suvannasankha
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor-investigator, Attaya Suvannasankha, Indiana University
- Investigators
- Attaya Suvannasankha, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540644
- Sponsor's protocol ID
- 0704-06; IUCRO-0170
- Status last verified
- May 2016
- First submitted
- 5 Oct 2007
- Last updated
- 21 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00540644
- Acronym / sponsor ID
- 0704-06; IUCRO-0170
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Revlimid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Attaya SuvannasankhaUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Oct 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Posted 21 Jun 2016
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 to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.
Detailed description
This is a phase II single institution trial in patients with newly diagnosed multiple myeloma. Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revlimid, Cyclophosphamide, Prednisone | Experimental | Drug: lenalidomide (Revlimid®), Drug: Cyclophosphamide, Drug: PrednisoneLenalidomide orally on Days 1-21 followed by 7 days rest, repeated every 28 days. Cyclophosphamide twice daily, orally on Days 1-21 followed by 7 days rest, repeated every 28 days. Prednisone every other day orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients with newly diagnosed, symptomatic multiple myeloma based on the following criteria:
- Presence of an M-component in serum and/or urine plus clonal plasma cells in the bone marrow and/or a documented clonal plasmacytoma
- Calcium elevation (11.5 mg/dl) [42.65 mmol/l]
- Renal insufficiency (1.5 x the ULN of serum creatinine)
- Anemia (hemoglobin <=10 g/dl or 2 g/dl <= normal)
Key exclusion criteria (6 listed)
- Known hypersensitivity to thalidomide
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Patients with a solitary plasmacytoma
- Patients with uncontrolled diabetes
- Patients with ≥ Grade 3 sensory neuropathy
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 |
|---|---|---|
| lenalidomide (Revlimid®)Also: Revlimid®25 mg p.o. daily on days 1-21 of each 28 day cycle | Drug | Revlimid, Cyclophosphamide, Prednisone |
| Cyclophosphamide50 mg p.o. BID daily on days 1-21 of each 28 day cycle | Drug | Revlimid, Cyclophosphamide, Prednisone |
| Prednisone50 mg p.o. Q.O.D. | Drug | Revlimid, Cyclophosphamide, Prednisone |
Primary outcome
Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
Time frame: After 6 cycles
Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.
2 secondary outcomes
Treatment Related Adverse Events Grade 3 or Higher
Time frame: Beginning of treatment up to 5 years
Quality of Life Using the FACT-G Data
Time frame: baseline and after last cycle (up to 6 cycles)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- 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.
Attaya Suvannasankha, M.D. principal investigator
Indiana University
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 lenalidomide (Revlimid®), Cyclophosphamide and Prednisone in people with Multiple Myeloma, run by Attaya Suvannasankha 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 20 inclusion and 6 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 21 Jun 2016. 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?
Yes. Results are posted in the registry (first posted 21 Jun 2016). 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?
Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria (time frame: After 6 cycles). 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 2016.