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

This study is ongoing, but not recruiting participants.
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: October 29, 2012
Last updated: March 6, 2017
Last verified: March 2017

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
Drug: Lenalidomide
Drug: MLN9708
Radiation: Questionnaires
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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 ]
    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: 88
Actual Study Start Date: December 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01718743

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Millennium Pharmaceuticals, Inc.
Principal Investigator: Robert Orlowski, MD, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01718743     History of Changes
Other Study ID Numbers: 2012-0277
NCI-2012-02873 ( Registry Identifier: NCI CTRP )
Study First Received: October 29, 2012
Last Updated: March 6, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Post Autologous Stem Cell Transplant

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Protease Inhibitors processed this record on April 28, 2017