Completed

Randomized Phase 2 Trial of Retreatment With Pomalidomide or Lenalidomide With Dexamethasone for Patients With Relapsed Myeloma

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What is being tested

Dexamethasone

+ Lenalidomide

+ Dexamethasone

Drug
Who is being recruted

Blood Protein Disorders+12

+ Cardiovascular Diseases

+ Hematologic Diseases

Over 18 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2014
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: August 21, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2014

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. To assess the confirmed response rate of the combination of lenalidomide and dexamethasone in patients with relapsed myeloma who have previously become refractory to lenalidomide. (Arm A) II. To assess the confirmed response rate of the combination of pomalidomide and dexamethasone in patients with relapsed myeloma who have previously become refractory to lenalidomide. (Arm B) SECONDARY OBJECTIVES: I. To assess the toxicity in each arm in patients with relapsed myeloma who have previously received lenalidomide. II. To assess the response rates with pomalidomide and dexamethasone in patients relapsing on lenalidomide and dexamethasone. (Arm A) III. To assess time to progression and overall survival with each approach. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive lenalidomide orally (PO) daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B. ARM B: Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

NCT01794039
Principal SponsorMayo Clinic
Last updated: August 21, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

9 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeParaproteinemiasVascular DiseasesHemostatic DisordersNeoplasms, Plasma CellMultiple Myeloma

Criteria

12 inclusion criteria required to participate
(Untransfused) platelet count >= 50000/uL
A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Absolute neutrophil count >= 1000uL
Calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula
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9 exclusion criteria prevent from participating
Diagnosed active deep vein thrombosis (DVT) that has not been therapeutically anticoagulated
Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.)
New York Heart Association classification III or IV
Nursing women (lactating females must agree not to breast feed while taking lenalidomide)
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B.

Group II

Experimental
Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Mayo Clinic

Rochester, United StatesOpen Mayo Clinic in Google Maps
CompletedOne Study Center