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STUDY TO DETERMINE THE EFFICACY AND SAFETY OF STANDARD SCHEDULE VERSUS A NEW ALGORITHM OF DOSE REDUCTIONS IN ELDERLY AND UNFIT NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS RECEIVING LENALIDOMIDE PLUS STEROIDS

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ClinicalTrials.gov Identifier: NCT02215980
Recruitment Status : Active, not recruiting
First Posted : August 13, 2014
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione Neoplasie Sangue Onlus

Brief Summary:
This protocol is a phase III multicenter, randomized, controlled study designed to assess the safety and the efficacy of standard schedule versus a new algoritm of dose reductions in elderly and unfit newly diagnosed Multiple Myeloma (MM) patients receiving lenalidomide plus steroids.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Lenalidomide Drug: Dexamethasone Phase 3

Detailed Description:

TREATMENT PERIOD:

Arm A: Rd

  • Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21.
  • Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days until progression or intolerance.

Arm B: Rd-R (reduced)

  • Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21
  • Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days, for a total of 9 cycles.

Maintenance until progression or intolerance:

- Lenalidomide: 10 mg/daily on days 1-21 of each 28-day cycle

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE III, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF STANDARD SCHEDULE VERSUS A NEW ALGORITHM OF DOSE REDUCTIONS IN ELDERLY AND UNFIT NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS RECEIVING LENALIDOMIDE PLUS STEROIDS
Actual Study Start Date : July 2014
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: A
  • Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21.
  • Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days until progression or intolerance.
Drug: Lenalidomide
Drug: Dexamethasone
Experimental: B
  • Lenalidomide: at the dose of 25 mg/daily as oral administration (PO) on days 1-21
  • Dexamethasone: at the dose of 20 mg as oral administration (PO) once weekly. Each cycle will be repeated every 28 days, for a total of 9 cycles.

Maintenance until progression or intolerance:

- Lenalidomide: 10 mg/daily on days 1-21 of each 28-day cycle

Drug: Lenalidomide
Drug: Dexamethasone



Primary Outcome Measures :
  1. Event-free survival [ Time Frame: 3 years ]

    Determine the Event-free survival defined as:

    • Progression
    • Death for any cause
    • Discontinuation of lenalidomide therapy
    • Occurrence of any haematological grade 4 or non-haematological grade 3-4 adverse events (AES), including Secondary Primary Malignancies (SPMs)


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 5 years ]
  2. Overall survival (OS) [ Time Frame: 5 years ]
  3. Time to progression (TTP) [ Time Frame: 5 years ]
  4. Overall response rate (ORR) [ Time Frame: 5 years ]
  5. Time to response (TTR) [ Time Frame: 5 years ]
  6. Duration of response (DOR) [ Time Frame: 5 years ]
  7. Time to the next therapy (TNT) [ Time Frame: 5 years ]
  8. Incidence of dose reduction and drug discontinuation [ Time Frame: 5 years ]
  9. Health care cost [ Time Frame: 5 years ]
  10. Correlation between tumor response and outcome with baseline prognostic factors [ Time Frame: 5 years ]
    Analysis of tumor response and outcome stratification by prognostic factors

  11. Quality of life assessment (HRQOL) [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients >65 years unfit and unsuitable, according to the investigator's opinion, to receive approved first line treatments for newly diagnosed MM.
  • Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
  • Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
  • Symptomatic MM based on standard CRAB criteria (5).
  • Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, ≥ 0.5 g/dL of M-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours. For patients with oligo or non-secretory MM, it is required that they have measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an abnormal free light chain ratio (n.v.: 0.26-1.65). We anticipate that less than 10% of patients admitted to this study will be oligo- or non-secretory MM with free light chains only in order to maximize interpretation of benefit results.
  • All randomized patients will be selected based on the use of 3 geriatric scales: IADL, ADL, Charlson. Unfit patients with clinical sign of frailty (mild, moderate or severe frailty), including need help for household tasks and personal care can be enrolled in this trial (2,4).
  • In order to include patients who normally are not select for clinical trials, also patients with the following abnormal laboratory values can be considered:

    1. absolute neutrophil count (ANC) < 1 x 10^9/L
    2. platelet count < 80 x 10^9/L
    3. haemoglobin < 8 g/dl.
    4. aspartate transaminase (AST): < 5 x the upper limit of normal (ULN).
    5. alanine transaminase (ALT): < 5 x the ULN.
    6. total bilirubin: > 1.5 x the ULN
    7. calculated or measured creatinine clearance: <30 mL/minute

The geriatric assessment evaluations will select unfit patients to be randomized regardless of possible abnormal laboratory values at the study entry.

Exclusion Criteria:

  • Pregnant or lactating females.
  • Male patients not agreeing to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study.
  • Females of childbearing potential not agreeing to use two acceptable methods for contraception (e.g. a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  • Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid < to the equivalent of dexamethasone 40 mg/day for 4 days).
  • Any significant medical disease or conditions that, in the investigator's opinion, may interfere with protocol adherence or subject's ability to give informed consent or could place the subject at unacceptable risk.
  • Presence of clinical active infectious hepatitis type B or C, classified into Child-Pugh class C (see Appendix V) and HIV.
  • Presence of acute active infection requiring antibiotics or infiltrative pulmonary disease.
  • Contraindication to any of the required drugs or supportive treatments.
  • Presence of prior history of malignancies, other than multiple myeloma, with a life expectancy < 2 years.
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215980


Locations
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Italy
FO.NE.SA.Onlus
Torino, Italy, 10126
Sponsors and Collaborators
Fondazione Neoplasie Sangue Onlus

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Responsible Party: Fondazione Neoplasie Sangue Onlus
ClinicalTrials.gov Identifier: NCT02215980    
Other Study ID Numbers: RV-MM-PI-0752
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Keywords provided by Fondazione Neoplasie Sangue Onlus:
Multiple myeloma
Diagnosis
Elderly and unfit patients
Lenalidomide plus steroids
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors