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An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of MLN9708, a Next-Generation Proteasome Inhibitor, Administered in Combination With a Standard Care Regimen of Melphalan and Prednisone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of MLN9708, a Next-Generation Proteasome Inhibitor, Administered in Combination With a Standard Care Regimen of Melphalan and Prednisone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment


Inclusion Criteria:



- Male or female patient for whom standard melphalan prednisone (MP) treatment is
indicated and who is not a candidate for high-dose therapy plus stem cell
transplantation (HDT-SCT) for 1 of the following reasons: the patient is 65 years of
age or older OR the patient is less than 65 years of age but has significant comorbid
condition(s) that are likely to have a negative impact on tolerability of HDT-SCT

- Symptomatic multiple myeloma or asymptomatic myeloma with myeloma-related organ
damage diagnosed according to standard criteria

- Measurable disease as specified in study protocol

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

- Must have adequate hematologic, liver, and renal function

- Female patients who are post menopausal, surgically sterile, or agree to practice 2
effective methods of contraception or agree to abstain from heterosexual intercourse

- Male patients who agree to practice effective barrier contraception or agree to
abstain from heterosexual intercourse

- Voluntary written consent

Exclusion Criteria

- Peripheral neuropathy that is greater or equal to Grade 2

- Female patients who are lactating or pregnant

- Major surgery or radiotherapy within 14 days before the first dose of study drug

- Uncontrolled infection requiring systematic antibiotics

- Diarrhea (> Grade 1)

- Prior systemic therapy for multiple myeloma, including investigational drugs (prior
treatment with corticosteroids or localized radiation therapy dose not disqualify the
patient)

- Central nervous system involvement

- Cardiac status as described in protocol

- Known gastrointestinal condition or procedure that could interfere with swallowing or
the oral absorption of tolerance of MLN9708

- Diagnosis of smoldering multiple myeloma, Waldenstrom's macroglobulinemia, POEMS
syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or
myeloproliferative syndrome

- Known human immunodeficiency virus (HIV) positive, hepatitis B surface
antigen-positive status, or known or suspected active hepatitis C infection

- Diagnosed or treated for another malignancy within 2 years before the first dose or
previously diagnosed with another malignancy and have any evidence of residual
disease with the exception of nonmelanoma skin cancer or any completely resected
carcinoma in situ

- Serious medical or psychiatric illness that could, in the investigator's opinion,
potentially interfere with the completion of treatment according to the protocol

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose and Recommended phase 2 dose of MLN9708 (phase 1)

Outcome Description:

Based on toxicity and efficacy outcomes

Outcome Time Frame:

Dose Limiting Toxicities determined in Cycle 1 and adverse events monitored throughout the study will inform the recommended phase 2 dose, approximately 2 years

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C16006

NCT ID:

NCT01335685

Start Date:

June 2011

Completion Date:

January 2015

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Emory UniversityAtlanta, Georgia  30322
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
Mary Babb Randolph Cancer Center/WVUMorgantown, West Virginia  26506