Continuous Lenalidomide Therapy Versus Observation Following Induction Without Lenalidomide, Pomalidomide or Thalidomide in Myeloma

NCT02155634 | Withdrawn Phase 3 DMC

• 1 other identifier: CC-5013-MM-027
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to see how long lenalidomide therapy can maintain or improve the disease response obtained after induction therapy that does not include lenalidomide, pomalidomide or thalidomide; and consequently reduce worsening of disease and to evaluate the activity of lenalidomide. Patients will receive lenalidomide or be under observation. All patients will attend regular clinic visits to evaluate their disease and health. Patients will have the option to participate in additional biomarker correlative studies in addition to their participation in the main study.

Conditions

Multiple Myeloma; Neoplasms; Plasma Cells; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Therapeutic Uses

Keywords

Newly Diagnosed Multiple Myeloma; Multiple Myeloma; Lenalidomide; Revlimid; Phase III; Phase IIIb; Plasma Cell Dyscrasia

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Time from randomization to the documentation of disease progression

  Approximately 36 months.

Secondary Outcomes (4)

• Response Rate

  Approximately 36 months

• Time to progression (TTP)

  Approximately 36 months

• Overall survival (OS)

  Approximate 6.5 years

• Safety

  Approximate 6.5 years

Study Arms (2)

Lenalidomide

EXPERIMENTAL

Lenalidomide maintenance given until disease progression. Long term follow-up 5 years post last patient randomized.

Drug: Lenalidomide

Observation

NO INTERVENTION

Observation until disease progression. Long term follow-up 5 years post last patient randomized.

Interventions

Lenalidomide DRUG

Treatment with lenalidomide capsules 10 mg, 5mg daily or 5mg every other day given on days 1-21 of each 28 day cycle.

Also known as: Revlimid

Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated and symptomatic multiple myeloma (MM).
• MM diagnosis meeting all 3 diagnostic criteria of (1) monoclonal plasma cells in the bone marrow ≥ 10% and/or presence of a biopsy-proven, plasmacytoma, (2) monoclonal protein in the serum and/or urine, and (3) at least one criteria of hypercalcemia, renal failure, anemia or bone disease.
• Measurable disease by protein electrophoresis analyses.
• All subjects must be treated with a minimum of 6 cycles (unless subject achieved a complete response prior to 6 cycles),and a maximum of 12 cycles of induction without lenalidomide (LEN), pomalidomide (POM) or thalidomide (THAL). Subject must have achieved at least stable disease (SD) as best overall response and maintained SD or better throughout the induction until screening. Subjects who plateau must have at least 2 cycles at best response prior to randomization.
• Subjects must have cytogenetic (e.g.:17 p deletion, and 4;14 translocation), β-2 microglobulin and serum albumin (ISS Stage) results from their initial diagnosis available at the time of screening.
• Related to the subject
• Must understand and voluntarily sign the informed consent document (ICD) prior to the conduct of any study related assessments/procedures,
• Age ≥ 65 years: if \< 65 years of age, the subject must be non eligible for or decline stem cell transplant,
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2,
• Able to adhere to the study visit schedules and other protocol requirements,
• Females of Childbearing Potential \* (FCBP) must:
• Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence\*\* from heterosexual contact.
• Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting investigational product (IP), during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
• Male Subjects must:
• Practice true abstinence\*\* or agree to use a condom during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions and for at least 28 days following IP discontinuation, even if he has undergone a successful vasectomy.

You may not qualify if:

• The presence of any of the following will exclude the subject from the study enrollment:
• Previous treatment with anti-myeloma therapy other than the required 6-12 cycles of induction without LEN, POM or THAL (does not include local radiotherapy, bisphosphonates, or a single short course of steroid \[ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization\]).
• Subjects who did not achieve SD or better after getting at least 6 cycles of induction are not eligible.
• Non-secretary MM.
• Prior therapy with LEN, POM, THAL or Melphalan. Subjects who received investigational agents are also excluded.
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Pregnant or lactating females.
• Any of the following laboratory abnormalities:
• Absolute Neutrophil Count (ANC) \< 1,000/µL (1.0 x 109/L)
• Untransfused platelet count \< 50,000 cells/µL (50 x 109/L)
• Serum aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SPGT) \> 3.0 x upper limit of normal (ULN)
• Serum bilirubin levels \> 1.5 x ULN
• Severe renal insufficiency (creatinine clearance \[CrCl\] \< 30 mL/min by Cockcroft-Gault method) or actual CrCl result requiring hemodialysis or peritoneal dialysis.
• Prior history of malignancies including skin cancer, other than multiple myeloma, with exception of basal cell carcinoma and squamous cell carcinoma in situ.
• Prior history of deep vein thrombosis or pulmonary embolism within 3 years of randomization.

Sponsors & Collaborators

• Celgene: lead

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yasir Nagarwala, MD

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: March 1, 2021
• Last Updated: April 10, 2018

Record last verified: 2018-04