NCT00478218 · REGISTRY CONDITION SEARCH

Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating 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: 2011-08-31

RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may kill more cancer cells.\> PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating 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

Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Progression-free Survival (PFS)

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outcome · POSTED

Duration of Response (DOR)

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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: DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma * Newly diagnosed disease * Symptomatic disease * Measurable or evaluable disease, defined by ≥ 1 of the following criteria: * Serum monoclonal protein ≥ 1.0 g by protein electrophoresis * Monoclonal protein \> 200 mg by 24-hour urine electrophoresis * Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio * Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease) * Measurable soft tissue plasmacytoma not previously irradiated * No monoclonal gammopathy of undetermined significance or smoldering myeloma PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if secondary to pain) * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL * Creatinine ≤ 2.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for 1 month before, during, and for 4 weeks after completion of study therapy * No uncontrolled infection * No other active malignancy * No other malignancies within the past 5 years except for currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast * No NYHA class III-IV congestive heart failure * No untreated active deep vein thrombosis PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior radiotherapy for solitary plasmacytoma * Prior clarithromycin, therapeutic dehydroepiandrosterone (DHEA), anakinra, pamidronate disodium, or zoledronic acid allowed * No prior cytotoxic chemotherapy * No prior corticosteroids (except for treatment of a nonmalignant disorder) * Concurrent corticosteroids (prednisone ≤ 20 mg/per day) allowed * No concurrent radiotherapy except palliative radiotherapy for a single painful bone lesion or fracture
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: cyclophosphamide
Drug: dexamethasone
Drug: lenalidomide
label
Lenalidomide/Cyclophosphamide/Dexamethasone
type
EXPERIMENTAL

interventions

arm Group Labels
Lenalidomide/Cyclophosphamide/Dexamethasone
description
300 mg/m2 administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles) OR 300 mg administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles)
name
cyclophosphamide
other Names
Cytoxan, CTX, Neosar®
type
DRUG
arm Group Labels
Lenalidomide/Cyclophosphamide/Dexamethasone
description
40 mg administrated by PO (with food)on Days 1, 8, 15 \& 22
name
dexamethasone
other Names
Decadron
type
DRUG
arm Group Labels
Lenalidomide/Cyclophosphamide/Dexamethasone
description
25 mg administrated by PO (with food)on Days 1-21
name
lenalidomide
other Names
Revlimid®
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 53
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Response that was confirmed on 2 consecutive evaluations during treatment * Complete Response(CR): Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM) * Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100 mg per 24 hours; \<=5% plasma cells in BM * Partial Response PR): \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels
measure
Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment
time Frame
Duration of Treatment (up to 5 years)

secondary Outcomes

description
OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.
measure
Overall Survival (OS)
time Frame
up to 5 years
description
PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.\> Progression was defined as any one or more of the following:\> An increase of 25% from lowest confirmed response in:\> * Serum M-component (absolute increase \>= 0.5g/dl)\> * Urine M-component (absolute increase \>= 200mg/24hour\> * Difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl\> * Bone marrow plasma cell percentage (absolute increase of \>=10%)
measure
Progression-free Survival (PFS)
time Frame
up to 5 years
description
Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. The median DOR with 95%CI was estimated using the Kaplan Meier method.
measure
Duration of Response (DOR)
time Frame
up to 5 years

Full study description

brief Summary: RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may kill more cancer cells.\> PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with newly diagnosed multiple myeloma.
detailed Description: OBJECTIVES: Primary \* Assess the response rate in patients with newly diagnosed active multiple myeloma treated with lenalidomide, cyclophosphamide, and dexamethasone. Secondary * Assess the toxicity of this regimen in these patients. * Determine the time to progression in patients treated with this regimen. OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide on days 1, 8, and 15, and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for up to 5 years.

Source references

references

citation
Kumar SK, Lacy MQ, Hayman SR, Stewart K, Buadi FK, Allred J, Laumann K, Greipp PR, Lust JA, Gertz MA, Zeldenrust SR, Bergsagel PL, Reeder CB, Witzig TE, Fonseca R, Russell SJ, Mikhael JR, Dingli D, Rajkumar SV, Dispenzieri A. Lenalidomide, cyclophosphamide and dexamethasone (CRd) for newly diagnosed multiple myeloma: results from a phase 2 trial. Am J Hematol. 2011 Aug;86(8):640-5. doi: 10.1002/ajh.22053. Epub 2011 May 31.
pmid
21630308
type
RESULT

Source notices and limitations

Discovery and provenance

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exact text
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source url
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Preserved source evidence · Not medical advice