NCT00540644 · REGISTRY CONDITION SEARCH

Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2016-06-21

The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria

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outcome · POSTED

Treatment Related Adverse Events Grade 3 or Higher

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outcome · POSTED

Quality of Life Using the FACT-G Data

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 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) * 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 Exclusion Criteria: * 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: lenalidomide (Revlimid®)
Drug: Cyclophosphamide
Drug: Prednisone
label
Revlimid, Cyclophosphamide, Prednisone
type
EXPERIMENTAL

interventions

arm Group Labels
Revlimid, Cyclophosphamide, Prednisone
description
25 mg p.o. daily on days 1-21 of each 28 day cycle
name
lenalidomide (Revlimid®)
other Names
Revlimid®
type
DRUG
arm Group Labels
Revlimid, Cyclophosphamide, Prednisone
description
50 mg p.o. BID daily on days 1-21 of each 28 day cycle
name
Cyclophosphamide
type
DRUG
arm Group Labels
Revlimid, Cyclophosphamide, Prednisone
description
50 mg p.o. Q.O.D.
name
Prednisone
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 70
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
time Frame
After 6 cycles

secondary Outcomes

description
Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.
measure
Treatment Related Adverse Events Grade 3 or Higher
time Frame
Beginning of treatment up to 5 years
description
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
measure
Quality of Life Using the FACT-G Data
time Frame
baseline and after last cycle (up to 6 cycles)

Full study description

brief Summary: 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..

Source references

Source notices and limitations

Discovery and provenance

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primary nct id
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source kind
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source url
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occurrences
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exact text
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query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice