Thalidomide to Overcome Lenalidomide Resistance After Autologous Hematopoietic Stem Cell Transplantation (HCT)

NCT01927718 | Terminated Results

• 2 other identifiers: 2011-0806NCI-2014-00157
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if adding low dose Thalidomide (thalidomide) to Revlimid (lenalidomide) maintenance therapy will help control MM after an autologous stem cell transplant. Researchers also want to learn if treatment with these study drugs will improve participants' quality of life.

Conditions

Myeloma

Keywords

Blood And Marrow Transplantation; Myeloma; Multiple myeloma; MM; Autologous stem cell transplantation; ASCT; Thalidomide; Thalomid; Lenalidomide; CC-5013; Revlimid; Questionnaires; Surveys

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Response

  Primary endpoint is response rate (RR) measured by the proportion of patients receiving the combination, whose disease stabilizes, or returns to at least its previous response level prior to progression, assessed at 3-months after starting the combination.1.Stringent Complete Remission (sCR): Follows criteria for CR, plus:Normal FLC ratio, Absence of clonal cells in the BM; Complete Remission (CR) All of the following criteria are met:Negative SIFE and UIFE:Disappearance of any soft tissue plasmacytomas:\< 5% plasma cells in the BM. 2.Very Good Partial Response (VGPR):One or more of the following must be present:Serum and urine M-protein detectable by immunofixation but not on electrophoresis:≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours.Partial Response (PR) Both of the following must be present:≥ 50% reduction in SPEP:Reduction in 24-hour UPEP by ≥ 90% or to \< 200 mg/24 hours.3.Stable Disease (SD)Does not meet the criteria for CR, VGPR, PR, or PD.4.Pr

  3 months

Study Arms (1)

Thalidomide + Lenalidomide

EXPERIMENTAL

Thalidomide 100 mg by mouth daily for 28 days in a 28 day cycle started after the clinical documentation of biochemical progression. Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 days on a 28 day cycle.

Drug: Thalidomide; Drug: Lenalidomide; Behavioral: Questionnaires

Interventions

Thalidomide DRUG

100 mg by mouth daily for 28 days in a 28 day cycle.

Also known as: Thalomid

Thalidomide + Lenalidomide

Lenalidomide DRUG

Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 days on a 28 day cycle.

Also known as: CC-5013, Revlimid

Thalidomide + Lenalidomide

Questionnaires BEHAVIORAL

Questionnaire completion at screening, once a month for the first 6 months, then every other month while on study.

Also known as: Surveys

Thalidomide + Lenalidomide

Eligibility Criteria

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

You may qualify if:

• Patient or legally authorized representative able to sign an informed consent form.
• Age 18 years old or older.
• Multiple myeloma showing signs of biochemical progression while taking lenalidomide or lenalidomide plus dexamethasone maintenance therapy after autologous hematopoietic stem cell transplantation. (Progression is defined solely based on serum or urine M-protein, or in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved serum free light chain level -- please also see appendix E for full details.)
• Patients with biochemical progression only with at least \>/= 25% increase from the baseline in any of the following parameters on at least 2 occasions; and when the treating physician deems a change in therapy is necessary: a. Serum M-protein; b. Urine M-protein; or, c. In patients without measureable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels.
• Lenalidomide must have been used for at least 6 months after autologous hematopoietic stem cell transplantation with the current dose of Lenalidomide 15 mg/day or less.
• Serum creatinine clearance (Cockcroft-Gault Equation) \>= 50 mL/minute.
• Performance score of at least 80% by Karnofsky or 0 to 2 Eastern Cooperative Oncology Group (ECOG).
• Patients must be informed of the Celgene Risk Management Program and mandatory registration as well as be willing and able to comply with its requirements.
• Negative Beta Human Chorionic Gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to ongoing pregnancy testing while on treatment with lenalidomide.
• Woman with child bearing potential must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME.
• Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy.
• Laboratory test results within these ranges: a. Absolute neutrophil count \> 1000 cells/mm3. b. Platelet count \> 50,000 cells/mm3 for patients with \< 50% of bone marrow plasma cells OR platelet count \> 25,000 cells/mm3 for patients in whom \> 50% of the bone marrow nucleated cells were plasma cells. c. Total bilirubin \</= 2.0 mg/dL. d. AST (SGOT) and ALT (AGPT) \</= 3 x upper normal limit.
• Able to take anticoagulation, warfarin or equivalent agent, as detailed in the treatment plan.
• HIV negative.

You may not qualify if:

• Any serious medical condition or psychiatric illness that would prevent the subject from signing the informed consent form.
• Patients with symptomatic relapse, including those with new bone lesions, soft tissue plasmacytomas, an increase in the size of existing bone lesions or soft tissue plasmacytomas, decrease in hemoglobin, rise in serum creatinine or hypercalcemia.
• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
• Known hypersensitivity to thalidomide or lenalidomide.
• Known history of resistance to Thalidomide.
• Patients with grade III-IV neuropathy.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Multiple Myeloma

Interventions

Thalidomide; Lenalidomide; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic 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; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Qaiser Bashir, MD/Associate Professor, Stem Cell Transplantation
• Organization: UT MD Anderson Cancer Center

QBashir@mdanderson.org

713-792-7734

Study Officials

• Qaiser Bashir, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 23, 2013
• Study Start: January 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 29, 2019
• Results First Posted: April 29, 2019

Record last verified: 2019-04

Locations

US (1)