A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide (OCEAN)

January 29, 2024 updated by: Oncopeptides AB

A Randomized, Controlled, Open-label, Phase 3 Study of Melflufen/Dexamethasone Compared With Pomalidomide/Dexamethasone for Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Lenalidomide

This was a randomized, controlled, open-label, Phase 3 multicenter study which enrolled patients with RRMM following 2-4 lines of prior therapy and who were refractory to lenalidomide in the last line of therapy as demonstrated by disease progression on or within 60 days of completion of the last dose of lenalidomide. Patients received either melflufen+dex or pomalidomide+dex.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This was a randomized, controlled, open-label, Phase 3 multicenter study which enrolled patients with RRMM following 2-4 lines of prior therapy and who were refractory to lenalidomide in the last line of therapy as demonstrated by disease progression on or within 60 days of completion of the last dose of lenalidomide.

Patients were randomized to either one of two arms:

Arm A: Melphalan flufenamide (Melflufen) 40 mg on Day 1 and dexamethasone 40 mg on Days 1, 8, 15 and 22 of each 28-day cycle.

Arm B: Pomalidomide 4 mg daily on Days 1 to 21 and dexamethasone 40 mg on Days 1, 8, 15 and 22 of each 28-day cycle.

Patients ≥ 75 years of age received a reduced dose of dexamethasone of 20 mg on Days 1, 8, 15 and 22 for both Arm A and Arm B.

Patients were to receive treatment until such time as there was documented disease progression, unacceptable toxicity, or the patient/treating physician determined it was not in the patient's best interest to continue.

Dose modifications and delays in therapy may have been implemented based on patient tolerability as detailed in the protocol. In the event of a cycle delay, unrelated to dexamethasone toxicity, it was recommended to continue dexamethasone weekly.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
495

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
        • AT-02
      • Vienna, Austria
        • AT-01
  • Belgium
      • Edegem, Belgium
        • BE-05
      • Liège, Belgium
        • BE-03
      • Roeselare, Belgium
        • BE-02
  • Czechia
      • Brno, Czechia
        • CZ-05
      • Hradec Králové, Czechia
        • CZ-03
      • Olomouc, Czechia
        • CZ-04
      • Ostrava, Czechia
        • CZ-01
      • Praha, Czechia
        • Cz-02, Cz-06
  • Denmark
      • Vejle, Denmark
        • DK01
  • Estonia
      • Tallinn, Estonia
        • EE-01
      • Tartu, Estonia
        • EE-02
  • France
      • Brest, France
        • FR04
      • Cholet, France
        • FR-11
      • Le Mans, France
        • FR01
      • Limoges, France
        • FR05
      • Lyon, France
        • FR-07
      • Lyon, France
        • FR06
      • Mulhouse, France
        • FR03
      • Nice, France
        • FR-09
      • Poitiers, France
        • FR-08
      • Périgueux, France
        • FR-10
  • Greece
      • Athens, Greece
        • Gr02, Gr03
      • Pátra, Greece
        • GR04
      • Thessaloníki, Greece
        • GR01
  • Hungary
      • Budapest, Hungary
        • Hu02, Hu03, Hu04
      • Debrecen, Hungary
        • HU01
      • Kaposvár, Hungary
        • HU-06
      • Pécs, Hungary
        • HU-05
  • Israel
      • Jerusalem, Israel
        • IL03
      • Nahariya, Israel
        • IL01
      • Rehovot, Israel
        • IL05
      • Safed, Israel
        • IL02
      • Tel Aviv, Israel
        • IL04
      • Tel Aviv, Israel
        • IL06
  • Italy
      • Bergamo, Italy
        • IT07
      • Bologna, Italy
        • IT02
      • Brescia, Italy
        • IT08
      • Milano, Italy
        • It03, It09
      • Modena, Italy
        • IT06
      • Piacenza, Italy
        • IT04
      • Terni, Italy
        • IT05
      • Torino, Italy
        • IT01
  • Korea, Republic of
      • Busan, Korea, Republic of
        • KR-06
      • Daegu, Korea, Republic of
        • KR-05
      • Hwasun, Korea, Republic of
        • KR-04
      • Seul, Korea, Republic of
        • Kr-01, Kr-02, Kr-03
  • Lithuania
      • Kaunas, Lithuania
        • LT-02
      • Vilnius, Lithuania
        • LT-01
  • Netherlands
      • Rotterdam, Netherlands
        • NL01
  • Norway
      • Oslo, Norway
        • NO01
      • Ålesund, Norway
        • NO-02
  • Poland
      • Białystok, Poland
        • PL03
      • Chorzów, Poland
        • PL02
      • Lublin, Poland
        • PL05
      • Olsztyn, Poland
        • PL-08
      • Poznań, Poland
        • PL07
      • Rzeszów, Poland
        • PL04
      • Toruń, Poland
        • PL-09
      • Łódź, Poland
        • PL06
  • Romania
      • Braşov, Romania
        • RO-02
      • Bucharest, Romania
        • RO-01
  • Russian Federation
      • Ekaterinburg, Russian Federation
        • RU-05
      • Izhevsk, Russian Federation
        • RU-04
      • Krasnoyarsk, Russian Federation
        • Ru-11, Ru-14
      • Moscow, Russian Federation
        • RU-03
      • Nizhny Novgorod, Russian Federation
        • RU-09
      • Novosibirsk, Russian Federation
        • RU-10
      • Petrozavodsk, Russian Federation
        • RU-06
      • Saint Petersburg, Russian Federation
        • Ru-01, Ru-02, Ru-08, Ru-12, Ru-14
      • Samara, Russian Federation
        • RU-07
      • Syktyvkar, Russian Federation
        • RU-13
  • Spain
      • Badalona, Spain
        • ES11
      • Barcelona, Spain
        • Es02, Es13, Es14
      • Madrid, Spain
        • Es01, Es04, Es09
      • Málaga, Spain
        • ES-15
      • Pamplona, Spain
        • Es07, Es12
      • Salamanca, Spain
        • ES10
      • Santa Cruz de Tenerife, Spain
        • ES03
      • Sevilla, Spain
        • ES08
      • Valencia, Spain
        • Es05, Es06
  • Taiwan
      • Chiayi City, Taiwan
        • TW-02
      • Kaohsiung, Taiwan
        • Tw-04, Tw-07
      • Taichung, Taiwan
        • TW-03
      • Tainan, Taiwan
        • TW-05
      • Taipei, Taiwan
        • Tw-01, Tw-06
  • United Kingdom
      • Liverpool, United Kingdom
        • GB03
      • Manchester, United Kingdom
        • GB01
      • Milton Keynes, United Kingdom
        • GB02
      • Southampton, United Kingdom
        • GB04
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85711
        • US17
    • California
      • Fresno, California, United States, 93710
        • US01
    • Florida
      • Gainesville, Florida, United States, 32610
        • US11
      • Orange City, Florida, United States, 32763
        • US12
      • Plantation, Florida, United States, 33324
        • US-19
    • Idaho
      • Boise, Idaho, United States, 83712
        • US16
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • US-24
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • US13
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • US-27
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • US-21
      • Winston-Salem, North Carolina, United States, 27103
        • US-30
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • US06
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • US15
      • Temple, Texas, United States, 76504
        • US-18

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female, age 18 years or older
  2. A prior diagnosis of multiple myeloma with documented disease progression requiring further treatment at time of screening

  3. Measurable disease defined as any of the following:

    • Serum monoclonal protein ≥ 0.5 g/dL by protein electrophoresis.
    • ≥ 200 mg/24 hours of monoclonal protein in the urine on 24-hour electrophoresis
    • Serum free light chain ≥ 10 mg/dL AND abnormal serum kappa to lambda free light chain ratio
  4. Received 2-4 prior lines of therapy, including lenalidomide and a PI, either sequential or in the same line, and is refractory (relapsed and refractory or refractory) to both the last line of therapy and to lenalidomide (≥ 10 mg) administered within 18 months prior to randomization. Refractory to lenalidomide is defined as progression while on lenalidomide therapy or within 60 days of last dose, following at least 2 cycles of lenalidomide with at least 14 doses of lenalidomide per cycle.
  5. Life expectancy of ≥ 6 months
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  7. Females of child bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to start of treatment. Participants must agree to ongoing pregnancy testing. All patients must be willing to comply with all requirements of the USA pomalidomide Risk Evaluation and Mitigation Strategy (REMS) program or the pomalidomide Pregnancy Prevention Plan (PPP).
  8. Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
  9. 12-lead Electrocardiogram (ECG) with QT interval calculated by Fridericia Formula (QTcF) interval of ≤ 470 msec Fridericia Formula.

  10. The following laboratory results must be met during screening and also immediately before study drug administration on Cycle 1 Day 1:

    • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3 (1.0 x 10^9/L)
    • Platelet count ≥ 75,000 cells/mm^3 (75 x 10^9/L)
    • Hemoglobin ≥ 8.0 g/dl
    • Total Bilirubin ≤ 1.5 x upper limit of normal (ULN), or patients diagnosed with Gilberts syndrome, that have been reviewed and approved by the medical monitor.
    • Aspartate transaminase (AST /SGOT) and alanine transaminase (ALT/SGPT) ≤ 3.0 x ULN.
    • Renal function: Estimated creatinine clearance by Cockcroft-Gault formula ≥ 45 mL/min.
  11. Must be able to take antithrombotic prophylaxis.
  12. Must have, or be willing to have an acceptable central catheter. (Port a cath, peripherally inserted central catheter [PICC-line], or central venous catheter) (Insertion only required if randomized to Arm A).

Exclusion Criteria:

  1. Primary refractory disease (i.e. never responded (≥ MR) to any prior therapy)
  2. Evidence of mucosal or internal bleeding or platelet transfusion refractory
  3. Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study.
  4. Prior exposure to pomalidomide
  5. Known intolerance to IMiDs.
  6. Known active infection requiring parenteral or oral anti-infective treatment within 14 days of randomization.
  7. Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance.
  8. Pregnant or breast-feeding females
  9. Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation
  10. Known human immunodeficiency virus or active hepatitis C viral infection

  11. Active hepatitis B viral infection (defined as HBsAg+).

    • Patients with prior hepatitis B vaccine are permitted (defined as HBsAg-, Anti-HBs+, Anti-HBc-).
    • Non-active hepatitis B (HBsAg-, Anti-HBs+, Anti-HBc+) may be enrolled at the discretion of the investigator after consideration of risk of reactivation.
  12. Concurrent symptomatic amyloidosis or plasma cell leukemia
  13. POEMS syndrome
  14. Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 3 weeks (6 weeks for nitrosoureas) prior to randomization. IMiDs, PIs and or corticosteroids within 2 weeks prior to randomization. Other investigational therapies and monoclonal antibodies within 4 weeks of randomization. Prednisone up to but no more than 10 mg orally q.d. or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least 7 days prior to randomization
  15. Residual side effects to previous therapy > grade 1 prior to randomization (Alopecia any grade and/or neuropathy grade 2 without pain are permitted)
  16. Prior peripheral stem cell transplant within 12 weeks of randomization
  17. Prior allogeneic stem cell transplantation with active graft-versus-host-disease.
  18. Prior major surgical procedure or radiation therapy within 4 weeks of the randomization
  19. Known intolerance to steroid therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: Melflufen+Dexamethasone
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Drug: Dexamethasone
Oral tablets
Other Names:
  • Decadron
  • Fortecortin
  • Dex
Drug: Melflufen
Intravenous infusion
Other Names:
  • Melphalan Flufenamide
  • Pepaxti
Active Comparator: Arm B: Pomalidomide+Dexamethasone
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Drug: Dexamethasone
Oral tablets
Other Names:
  • Decadron
  • Fortecortin
  • Dex
Drug: Pomalidomide
Oral capsules
Other Names:
  • Pomalyst
  • Imnovid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From date of randomization until first evidence of confirmed disease progression or death due to any cause (whichever occurred first), up to the data cutoff date of 03 Feb 2021 (ie, assessed up to approximately 43 months).
Progression Free Survival defined as the duration in months from randomization until first evidence of confirmed disease progression, as assessed by the Independent Review Committee (IRC) according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Disease progression was defined according to the IMWG-URC as progressive disease or death due to any cause, whichever occurs first.
From date of randomization until first evidence of confirmed disease progression or death due to any cause (whichever occurred first), up to the data cutoff date of 03 Feb 2021 (ie, assessed up to approximately 43 months).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: From randomization until best response achieved before confirmed disease progression or death due to any cause, up to data cutoff of 03 Feb 2021 (ie, assessed up to approx. 43 months). Median time to best response: Arm A=2.1 months and Arm B=2.0 months
ORR defined as the proportion of patients for whom the best overall confirmed response is stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by IRC.
From randomization until best response achieved before confirmed disease progression or death due to any cause, up to data cutoff of 03 Feb 2021 (ie, assessed up to approx. 43 months). Median time to best response: Arm A=2.1 months and Arm B=2.0 months
Duration of Response (DOR)
Time Frame: From first documentation of a confirmed response to first evidence of confirmed disease progression or death due to any cause, up to the data cutoff date of 03 Feb 2021 (ie, assessed up to approximately 43 months).
DOR defined as the duration in months from first documentation of a confirmed response to first evidence of confirmed disease progression or death due to any cause.
From first documentation of a confirmed response to first evidence of confirmed disease progression or death due to any cause, up to the data cutoff date of 03 Feb 2021 (ie, assessed up to approximately 43 months).
Overall Survival (OS)
Time Frame: From date of randomization until up to 24 months following confirmed disease progression or initiation of subsequent therapy, up to the data cutoff date of 03 Feb 2023 (ie, assessed up to approximately 67 months).
OS defined as the time in months from randomization to date of death due to any cause. Patients who were still alive at end of study, or lost to follow up, were censored at the last day the patient was known to be alive.
From date of randomization until up to 24 months following confirmed disease progression or initiation of subsequent therapy, up to the data cutoff date of 03 Feb 2023 (ie, assessed up to approximately 67 months).
Safety and Tolerability: Number of Patients With Treatment-emergent Adverse Events (TEAEs), Including Clinical Laboratory and Vital Signs Abnormalities, as Assessed by CTCAE v4.0
Time Frame: From start of dosing until 30 days after the last dose of study treatment, up to the data cutoff date of 03 Feb 2023 (ie, assessed up to approximately 67 months). Median duration of study treatment was 25.2 and 22.1 weeks for Arm A and B, respectively.
Number of patients with TEAEs, including clinical laboratory and vital signs abnormalities, as assessed by CTCAE v4.0 are presented. No formal statistical analysis was performed for safety endpoints.
From start of dosing until 30 days after the last dose of study treatment, up to the data cutoff date of 03 Feb 2023 (ie, assessed up to approximately 67 months). Median duration of study treatment was 25.2 and 22.1 weeks for Arm A and B, respectively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oncopeptides AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pieter Sonneveld, Prof., Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OP-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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