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Multiple MyelomaPhase 3NCT02155634

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

A Phase 3 study testing Lenalidomide in people with Multiple Myeloma and Neoplasms, run by Celgene.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma, Neoplasms, Plasma Cells
What is being tested?
Lenalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2014to Mar 2021
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: Related to initial diagnosis and prior induction
  • 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.
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  • 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.
  • Agree to not donate semen during IP therapy and for 28 days after end of study therapy.
  • All subjects must:
  • Have an understanding that the study medication could have a potential teratogenic risk.
  • Agree to abstain from donating blood while taking IP therapy and following discontinuation of IP therapy.
  • Agree not to share study medication with another person.
  • All FCBP and male subjects must be counseled about pregnancy precautions and risks of fetal exposure.
  • An FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (ie, amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
  • True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (et, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].

Who cannot join

  • 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.
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  • 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.
  • Subjects who are unable or unwilling to undergo anti-thrombotic therapy.
  • Peripheral neuropathy of > Grade 2 severity according to the NCI CTCAE Version 4.0.
  • Known Human immunodeficiency virus positivity or active infectious hepatitis, type A, B, or C.
  • Primary amyloidosis (immunoglobulin light chain) and myeloma complicated by amyloidosis.
  • Prior allogeneic or autologous stem cell transplantation.
  • Significant active cardiac disease within the previous 6 months of signing the ICD including:
  • New York Heart Association class II-IV congestive heart failure
  • Unstable angina or angina requiring surgical or medical intervention
  • Myocardial infarction
  • Any condition that confounds the ability to interpret data from the study.

About this study

Official title: Phase 3b, Randomized Trial of Continuous Revlimid® (Lenalidomide) Therapy Versus Observation Following Induction Therapy That Does Not Include Revlimid, Pomalyst® or Thalomid® in Newly Diagnosed Multiple Myeloma

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.

Being tested
Lenalidomide
Keywords
Newly Diagnosed Multiple Myeloma, Multiple Myeloma, Lenalidomide, Revlimid, Phase III, Phase IIIb, Plasma Cell Dyscrasia
Medical subject headings
Multiple Myeloma, Neoplasms, Paraproteinemias, Blood Protein Disorders, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called Revlimid

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

Study groups in NCT02155634
Study groupRoleWhat they receive
LenalidomideExperimentalLenalidomide maintenance given until disease progression. Long term follow-up 5 years post last patient randomized.
Receives: Drug: Lenalidomide
ObservationNo interventionObservation until disease progression. Long term follow-up 5 years post last patient randomized.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    Time from randomization to the documentation of disease progression

    Measured: Approximately 36 months.

Secondary outcomes (4)

  1. Response Rate

    Response is defined according to the international Myeloma Working Group (IMWG) Response Criteria (Durie, 2006). Overall response rate over time (complete response [CR], very good partial response [VGPR], partial response [PR], stable disease [SD]

    Measured: Approximately 36 months

  2. Time to progression (TTP)

    The time to progression is defined from randomization to progression as defined by the international Myeloma Working Group (IMWG) Criteria (Durie, 2006)

    Measured: Approximately 36 months

  3. Overall survival (OS)

    Time from randomization to the date of death due to any cause

    Measured: Approximate 6.5 years

  4. Safety

    Number of patients with adverse events and relationship of adverse events, laboratory abnormalities, and hospitalizations to study drug / study observation

    Measured: Approximate 6.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionApr 2017 (estimated)
  4. Study completionMar 2021 (estimated)

Why it stopped: The study was terminated due to poor feasibility and lack of interest at the participating sites.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02155634
Sponsor's protocol ID
CC-5013-MM-027
Status last verified
Apr 2018
First submitted
2 Jun 2014
Last updated
10 Apr 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide in people with Multiple Myeloma and Neoplasms, run by Celgene.

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 24 inclusion and 25 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: withdrawn, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Progression free survival (PFS) (time frame: Approximately 36 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02155634.

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 10 Apr 2018.

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