MLN 9708 With Lenalidomide as Maintenance Post Autologous Stem Cell Transplant for Multiple Myeloma Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01718743
First received: October 29, 2012
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

The goal of this clinical research study is to learn if the combination of MLN9708 and Revlimid (also called lenalidomide or CC-5013) can help to control MM as maintenance treatment after an autologous stem cell transplant.

Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease or prevent the growth of cancer cells.

MLN9708 is designed to block a protein that plays a role in cell function and growth. This may cause cancer cells to die.


Condition Intervention Phase
Myeloma
Drug: Lenalidomide
Drug: MLN9708
Radiation: Questionnaires
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of the Combination of MLN 9708 With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression Free Survival (PFS) with Combination of MLN 9708 with Lenalidomide [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Progression free survival (PFS) defined as time from autologous stem cell transplantation (ASCT) to time of clinical progression, death, whichever occurs first or the time of last contact. PFS monitored using the method of Thall et al. (Thall, 2005).


Estimated Enrollment: 48
Study Start Date: December 2012
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide + MLN9708
Lenalidomide 10 mg by mouth every day in a 28 day cycle. After three months, the dose may be increased to 15 mg/day at discretion of physician. MLN9708 3 mg by mouth on days 1, 8, 15 in a 28 day cycle. Questionnaire completion on Day 1 of Cycle 1, 2 and beyond.
Drug: Lenalidomide
Starting dose: 10 mg by mouth every day in a 28 day cycle.
Other Names:
  • CC-5013
  • Revlimid
Drug: MLN9708
3 mg by mouth on days 1, 8, 15 in a 28 day cycle.
Radiation: Questionnaires
Questionnaire completion on Day 1 of Cycle 1, 2 and beyond.
Other Name: Surveys

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must have undergone autologous stem cell transplantation, with melphalan as a preparative regimen, within 12 months of initiation of induction therapy for newly diagnosed myeloma.
  2. Time to initiation of maintenance therapy. Patients may start maintenance therapy as early as 60 days post-transplant and up to 180 days post-transplant; as long as they meet the following criteria: * Platelet count >/= 100,000/mm^3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment. * Neutrophil count >/= 1000/mm^3. (No growth factors within 5 days prior to first dose of the study drug.) * Total bilirubin </= 1.5 x ULN * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </= 3 x ULN * Creatinine < 2.5 mg/dL * Recovered (ie, </= Grade 1 toxicity) from the reversible effects of autologous stem cell transplant.
  3. Patients whose primary therapy was changed due to suboptimal response of toxicity will be eligible, however no more than 2 regimens will be allowed prior to ASCT.
  4. Male or female patients 18 years or older.
  5. Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2.
  6. 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 subject at any time without prejudice to future medical care.
  7. Female patients who: Are postmenopausal for at least 1 year before the Screening visit, OR Are surgically sterile, OR If they are childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent, during study treatment and for 90 days after the last dose of study treatment, AND * Must also adhere to guidelines of any treatment-specific pregnancy prevention program, if applicable, OR *Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
  8. Male patients, even if surgically sterilized (ie, status post vasectomy),must agree to one of the following: Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study treatment, OR * Must also adhere to guidelines of any treatment-specific pregnancy prevention program, if applicable, OR *Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)

Exclusion Criteria:

  1. Patient has >/= Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
  2. Major surgery within 14 days before the first dose of study drug.
  3. Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708.
  4. Known active central nervous system involvement
  5. Systemic treatment, within 14 days before study enrollment, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort
  6. Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or GI procedure that could interfere with the oral absorption or tolerance of treatment.
  7. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
  8. Female subjects who are lactating or have a positive serum pregnancy test during the screening period.
  9. Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation or completion of treatment according to this protocol.
  10. QTcB > 470 milliseconds (msec) on a 12-lead ECG obtained during the Screening period. If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG.
  11. Ongoing or active systemic infection, known human immunodeficiency virus (HIV) positive, known active hepatitis B virus hepatitis, or known active hepatitis C virus hepatitis.
  12. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment.
  13. Known allergy to any of the study medications, their analogues, or excipients in the various formulations.
  14. Co-morbid systemic illnesses or other severe concurrent disease that, in the judgement of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  15. Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718743

Contacts
Contact: Jatin J. Shah, MD 713-792-2860

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Jatin J. Shah, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01718743     History of Changes
Other Study ID Numbers: 2012-0277, NCI-2012-02873
Study First Received: October 29, 2012
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Myeloma
Multiple Myeloma
MM
Post Autologous Stem Cell Transplant
Lenalidomide
CC-5013
Revlimid
MLN9708
Questionnaire
Survey

Additional relevant MeSH terms:
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
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 18, 2014