Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting
NCT ID: NCT01946477
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
186 participants
INTERVENTIONAL
2014-05-29
2025-05-26
Brief Summary
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This trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of \> 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide.
This trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of \> 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide.
This trial will test the hypothesis for Cohort C that the proportion of patients will have an Overall Response Rate (ORR) of \>60% to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This treatment will be in only Japanese patients.
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Detailed Description
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This trial will assess, Overall Response Rate (ORR), Overall Survival (OS), Progression-Free Survival (PFS), Duration of Response (DoR), Time to Response (TTR), Time to Progression(TTP) and safety.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pomalidomide + dexamethasone
Each subject enrolled in the study will take oral pomalidomide (4 mg) once daily on Days 1-21 and dexamethasone 40 mg/day (\< 75 years old) or 20 mg/day (\>75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.
Pomalidomide
Dexamethasone
Pomalidomide + Dexamethasone + Daratumumab
Each subject enrolled in the study will take oral pomalidomide (4 mg) once daily on Days 1-21 and dexamethasone 40 mg/day (\< 75 years old) or 20 mg/ day (\>75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle and daratumumab administered intravenously (IV) at a starting dose of 16 mg/kg at following schedule:
* Days 1, 8, 15, and 22 of a 28-day cycle for Cycle 1 and Cycle 2
* Days 1 and 15 for Cycle 3 through Cycle 6
* Day 1 for Cycle 7 and each cycle thereafter until disease progression
Pomalidomide
Dexamethasone
Daratumumab
Interventions
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Pomalidomide
Dexamethasone
Daratumumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Adults (age ≥ 18 years at the time of signing the ICD) with documented diagnosis of MM and measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours).
2. Subjects enrolling in Cohort A (POM+LD-dex) must have received 2 prior treatment lines of anti-myeloma therapy. Subjects enrolling in Cohort B and Cohort C (POM+DARA+LD-dex) must have received 1 or 2 prior treatment lines of anti-myeloma therapy.
3. All subjects must have received prior treatment with LEN or a LEN-containing regimen for at least 2 consecutive cycles as the most recent treatment regimen.
4. All subjects must have documented disease progression during or after their last antimyeloma therapy.
5. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
6. Subjects must understand and voluntarily sign an ICD prior to any study related assessments/procedures being conducted.
7. Subjects must be able to adhere to the study visit schedule and other protocol requirements.
8. All subjects must provide an adequate bone marrow sample at screening that definitively evaluates the presence or absence of myelodysplastic changes.
9. Females with child-bearing potential (FCBP†) must agree to use 2 reliable forms of contraception\* simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including during dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe. For subjects enrolled in Cohort B and Cohort C, pregnancy prevention and testing will continue until 3 months after last dose of daratumumab.
10. Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation. Female subjects enrolled in Cohort B and Cohort C must agree to abstain from breastfeeding and donating eggs during study participation and until 3 months after last dose of daratumumab.
11. Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy. Male subjects enrolled in Cohort B and Cohort C must agree to use a latex condom during any sexual contact with FCBP while participating in the study and until 3 months after last dose of daratumumab.
12. Males must also agree to refrain from donating semen or sperm during the treatment phase and for 28 days after discontinuation from this study treatment. Male subjects enrolled in Cohort B and Cohort C must also agree to refrain from donating semen or sperm during the treatment phase and until 3 months after last dose of daratumumab.
13. All subjects must agree to refrain from donating blood while on study therapy and for 28 days after discontinuation from this study treatment.
14. All subjects must agree not to share medication.
Exclusion Criteria
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1. Any of the following laboratory abnormalities:
• Absolute neutrophil count \< 1,000/μL
• Platelet count \< 75,000/μL for subjects in whom \< 50% of bone marrow nucleated cells are plasma cells; or a platelet count \< 30,000/μL for subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells.
• Severe renal impairment (Creatinine Clearance \[CrCl\] \< 30 mL/min) requiring dialysis.
* Corrected serum calcium \> 11.5 mg/dL (\> 2.8 mmol/L)
* Hemoglobin \< 8 g/dL (\< 4.9 mmol/L; prior red blood cell transfusion or recombinant human erythropoietin use is permitted)
* Serum SGOT/AST or SGPT/ALT \> 3.0 x the upper limit of normal (ULN)
* Serum total bilirubin \> 2.0 mg/dL (34.2 μmol/L); or \> 3.0 x ULN for subjects with hereditary benign hyperbilirubinemia
2. Prior history of malignancies, other than MM, unless the subject has been free of the disease for more than 5 years. Allowed exceptions include the following:
•Basal or squamous cell carcinoma of the skin
•Carcinoma in situ of the cervix or breast
• Incidental histological finding of prostate cancer (TNM \[tumor, nodes, metastasis\] stage of T1a or T1b)
3. Previous therapy with pomalidomide or daratumumab
4. Hypersensitivity to thalidomide, LEN, or dex (this includes ≥ Grade 3 rash during prior thalidomide or LEN therapy)
5. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment.
6. Subjects with any one of the following:
• Congestive heart failure (NY Heart Association Class III or IV)
* Myocardial infarction within 12 months prior to starting study treatment
* Unstable or poorly controlled angina pectoris, including Prinzmetal's variant angina pectoris
7. Subjects who received any of the following within 14 days of initiation of study treatment:
• Major surgery (kyphoplasty is not considered major surgery)
• Use of any anti-myeloma drug therapy
8. Use of any investigational agents including for the treatment of multiple myeloma within 28 days or 5 half-lives (whichever is longer) of treatment, unless approved by the sponsor.
9. Incidence of gastrointestinal disease that may significantly alter the oral absorption of Pomalidomide.
10. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
11. Any serious medical condition, laboratory abnormality, or psychiatric illness, that would preclude participation in the study, or interfere with interpretation of the study results
12. Pregnant or breastfeeding females
13. Known human immunodeficiency virus (HIV) positivity; active infectious hepatitis A, B, or C; or chronic hepatitis B or C
All subjects will be tested for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (antiHBs), and hepatitis B core antibody (antiHBc). Subjects with the following serological testing are considered not eligible:
* HBsAg positive
* HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA
Note:
* Subjects who are HBsAg negative, anti-HBs positive, and/or anti-HBc positive, viral DNA negative are eligible. For these subjects, DNA monitoring and prophylactic medication for HBV reactivation are recommended per local practice.
* Subjects who are seropositive because of hepatitis B virus vaccination are eligible (anti-HBs positive, anti-HBc negative, and HBsAg negative).
All subjects will be tested for hepatitis C antibody. Subjects are not eligible if known seropositive for hepatitis C virus.
Note:
• Subjects who are hepatitis C antibody positive but show no detectable viral RNA for 6 months prior to initiation of study treatment are eligible.
14. For subjects enrolling in Cohort B and Cohort C - Subject has known allergies, hypersensitivity to mannitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to the Daratumumab IB), or known sensitivity to mammalian-derived products.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 126
Tucson, Arizona, United States
Local Institution - 137
Greenbrae, California, United States
Local Institution - 109
Los Angeles, California, United States
Local Institution - 104
Pleasant Hill, California, United States
Local Institution - 108
Whittier, California, United States
Local Institution - 138
Denver, Colorado, United States
Local Institution - 120
Stamford, Connecticut, United States
Local Institution - 145
Jacksonville, Florida, United States
Local Institution - 127
Orlando, Florida, United States
Local Institution - 133
Pembroke Pines, Florida, United States
Local Institution - 136
St. Petersburg, Florida, United States
Local Institution - 134
Fairway, Kansas, United States
Local Institution - 142
Topeka, Kansas, United States
Local Institution - 124
Louisville, Kentucky, United States
Local Institution - 103
Westminster, Maryland, United States
Local Institution - 146
Gross Pointe, Michigan, United States
Local Institution - 102
Kansas City, Missouri, United States
Local Institution - 110
St Louis, Missouri, United States
Local Institution - 118
East Orange, New Jersey, United States
Local Institution - 101
Hackensack, New Jersey, United States
Local Institution - 129
Glens Falls, New York, United States
Local Institution - 149
The Bronx, New York, United States
Local Institution - 130
Durham, North Carolina, United States
Local Institution - 123
Cleveland, Ohio, United States
Local Institution - 121
Cleveland, Ohio, United States
Local Institution - 115
Cleveland, Ohio, United States
Local Institution - 122
Mayfield Heights, Ohio, United States
Local Institution - 107
Hershey, Pennsylvania, United States
Local Institution - 135
Chattanooga, Tennessee, United States
Local Institution - 131
Nashville, Tennessee, United States
Local Institution - 128
Lubbock, Texas, United States
Local Institution - 143
Plano, Texas, United States
Local Institution - 106
Spokane, Washington, United States
Local Institution - 113
Calgary, Alberta, Canada
Local Institution - 144
Surrey, British Columbia, Canada
Local Institution - 114
Vancouver, British Columbia, Canada
Local Institution - 139
Moncton, New Brunswick, Canada
Local Institution - 140
St. John's, Newfoundland and Labrador, Canada
Local Institution - 112
Toronto, Ontario, Canada
Local Institution - 148
Toronto, Ontario, Canada
Local Institution - 117
Montreal, Quebec, Canada
Local Institution - 205
Fukuoka, , Japan
Local Institution - 208
Kamogawa, , Japan
Local Institution - 204
Kyoto, , Japan
Local Institution - 202
Nagoya, , Japan
Local Institution - 203
Okayama, , Japan
Local Institution - 206
Shibukawa-shi, Gunma-ken, , Japan
Local Institution - 207
Toyohashi, , Japan
Local Institution - 119
San Juan, , Puerto Rico
Countries
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References
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Pelligra CG, Parikh K, Guo S, Chandler C, Mouro J, Abouzaid S, Ailawadhi S. Cost-effectiveness of Pomalidomide, Carfilzomib, and Daratumumab for the Treatment of Patients with Heavily Pretreated Relapsed-refractory Multiple Myeloma in the United States. Clin Ther. 2017 Oct;39(10):1986-2005.e5. doi: 10.1016/j.clinthera.2017.08.010. Epub 2017 Sep 28.
Bahlis NJ, Siegel DS, Schiller GJ, Samaras C, Sebag M, Berdeja J, Ganguly S, Matous J, Song K, Seet CS, Acosta-Rivera M, Bar M, Quick D, Anz B, Fonseca G, Chung W, Lee K, Mouro J, Agarwal A, Reece D. Pomalidomide, dexamethasone, and daratumumab immediately after lenalidomide-based treatment in patients with multiple myeloma: updated efficacy, safety, and health-related quality of life results from the phase 2 MM-014 trial. Leuk Lymphoma. 2022 Jun;63(6):1407-1417. doi: 10.1080/10428194.2022.2030477. Epub 2022 Feb 8.
Pierceall WE, Amatangelo MD, Bahlis NJ, Siegel DS, Rahman A, Van Oekelen O, Neri P, Young M, Chung W, Serbina N, Parekh S, Agarwal A, Thakurta A. Immunomodulation in Pomalidomide, Dexamethasone, and Daratumumab-Treated Patients with Relapsed/Refractory Multiple Myeloma. Clin Cancer Res. 2020 Nov 15;26(22):5895-5902. doi: 10.1158/1078-0432.CCR-20-1781. Epub 2020 Sep 14.
Siegel DS, Schiller GJ, Song KW, Agajanian R, Stockerl-Goldstein K, Kaya H, Sebag M, Samaras C, Malek E, Talamo G, Seet CS, Mouro J, Pierceall WE, Zafar F, Chung W, Srinivasan S, Agarwal A, Bahlis NJ. Pomalidomide plus low-dose dexamethasone in relapsed refractory multiple myeloma after lenalidomide treatment failure. Br J Haematol. 2020 Feb;188(4):501-510. doi: 10.1111/bjh.16213. Epub 2019 Oct 6.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CC-4047-MM-014
Identifier Type: -
Identifier Source: org_study_id
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