Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New combo shows promise for Tough-to-Treat blood cancer

NCT ID NCT01946477

Disease control Sponsor: Celgene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two drug combinations in 186 adults with multiple myeloma that came back or didn't respond after earlier treatment. One group got pomalidomide plus low-dose dexamethasone, and another got those two plus daratumumab. The goal was to see if the tumors shrank enough to qualify as a partial or complete response. The approach aims to control the disease, not cure it, and participants may need ongoing therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

186 people

The number who actually took part.

Started

May 2014

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects must satisfy the following criteria to be enrolled in the study: 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: The presence of any of the following will exclude a subject from study enrollment: <!-- --> 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Multiple myeloma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

neoplasm plasma cell myeloma plasmacytoma refractory plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • Local Institution - 101

    Hackensack, New Jersey, 07601, United States

  • Local Institution - 102

    Kansas City, Missouri, 64111, United States

  • Local Institution - 103

    Westminster, Maryland, 21157, United States

  • Local Institution - 104

    Pleasant Hill, California, 94523, United States

  • Local Institution - 106

    Spokane, Washington, 99218, United States

  • Local Institution - 107

    Hershey, Pennsylvania, 17033-0850, United States

  • Local Institution - 108

    Whittier, California, 90603, United States

  • Local Institution - 109

    Los Angeles, California, 90095-1670, United States

  • Local Institution - 110

    St Louis, Missouri, 63110, United States

  • Local Institution - 112

    Toronto, Ontario, M5G 2M9, Canada

  • Local Institution - 113

    Calgary, Alberta, T2N 2T9, Canada

  • Local Institution - 114

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Local Institution - 115

    Cleveland, Ohio, 44195, United States

  • Local Institution - 117

    Montreal, Quebec, H3A 1A1, Canada

  • Local Institution - 118

    East Orange, New Jersey, 07018, United States

  • Local Institution - 119

    San Juan, 00927, Puerto Rico

  • Local Institution - 120

    Stamford, Connecticut, 06902, United States

  • Local Institution - 121

    Cleveland, Ohio, 44111, United States

  • Local Institution - 122

    Mayfield Heights, Ohio, 44124, United States

  • Local Institution - 123

    Cleveland, Ohio, 44106, United States

  • Local Institution - 124

    Louisville, Kentucky, 40207, United States

  • Local Institution - 126

    Tucson, Arizona, 85724, United States

  • Local Institution - 127

    Orlando, Florida, 32804, United States

  • Local Institution - 128

    Lubbock, Texas, 79410, United States

  • Local Institution - 129

    Glens Falls, New York, 12801, United States

  • Local Institution - 130

    Durham, North Carolina, 27705, United States

  • Local Institution - 131

    Nashville, Tennessee, 37203, United States

  • Local Institution - 133

    Pembroke Pines, Florida, 33028, United States

  • Local Institution - 134

    Fairway, Kansas, 66205, United States

  • Local Institution - 135

    Chattanooga, Tennessee, 37404, United States

  • Local Institution - 136

    St. Petersburg, Florida, 33705, United States

  • Local Institution - 137

    Greenbrae, California, 94904-2007, United States

  • Local Institution - 138

    Denver, Colorado, 80218, United States

  • Local Institution - 139

    Moncton, New Brunswick, E1C 8X3, Canada

  • Local Institution - 140

    St. John's, Newfoundland and Labrador, A1B3V6, Canada

  • Local Institution - 142

    Topeka, Kansas, 66606, United States

  • Local Institution - 143

    Plano, Texas, 75093, United States

  • Local Institution - 144

    Surrey, British Columbia, V3V 1Z2, Canada

  • Local Institution - 145

    Jacksonville, Florida, 32256, United States

  • Local Institution - 146

    Gross Pointe, Michigan, 48236, United States

  • Local Institution - 148

    Toronto, Ontario, M5G 2M9, Canada

  • Local Institution - 149

    The Bronx, New York, 10467, United States

  • Local Institution - 202

    Nagoya, 467-8602, Japan

  • Local Institution - 203

    Okayama, 701-1192, Japan

  • Local Institution - 204

    Kyoto, 602-8566, Japan

  • Local Institution - 205

    Fukuoka, Fukuoka, 810-8563, Japan

  • Local Institution - 206

    Shibukawa-shi, Gunma-ken, 377-0280, Japan

  • Local Institution - 207

    Toyohashi, 441-8570, Japan

  • Local Institution - 208

    Kamogawa, 296-8602, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.