TerminatedNCT04700176Updated Feb 25, 2025Results posted

A Study of Daratumumab With Pomalidomide, Dexamethasone, and All-Transretinoic Acid in Patients With Multiple Myeloma

A Phase 2 interventional study of Daratumumab and Pomalidomide in Multiple Myeloma, sponsored by Hackensack Meridian Health. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-25.

Sponsored by Hackensack Meridian Health · Phase 2, Interventional, and Treatment

Why this study was terminated

Low Accrual

Phase: Phase 2
Study type: Interventional
Enrollment: 1
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to test the safety and efficacy of the study drug daratumumab, when given together with Pomalidomide, Dexamethasone, and All-Transretinoic Acid (ATRA).

Read the detailed description

This is a multi-institution phase II study of ATRA in combination with fixed dose Daratumumab, Pomalidomide and Dex for a total of 33 patients in patients with relapsed multiple myeloma who have progressed on the combination of Dara + Len + Dex. There will also be an exploratory cohort with an additional 10 patients who have progressed on the combination of Dara + Pom + Dex.

Conditions studied

Multiple Myeloma

Browse trials for

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 1 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Hackensack Meridian Health is the lead sponsor of 111 studies on the registry; 28 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 11 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Documented multiple myeloma
For cohort A, patients must have been previously exposed to Dara+Len+Dex and must have achieved at least stable disease to this combination.
For cohort B, patients must have been exposed to Dara + Pom + Dex and must have achieved at least stable disease to this combination.
Histologically confirmed and relapsed multiple myeloma with measurable disease, defined by at least one of the following:
1. Serum monoclonal protein ≥0.5 g/dL;
2. Monoclonal protein in the urine on 24-hour electrophoresis ≥200 mg;
3. Serum immunoglobulin free light chain (FLC) ≥10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal;
4. New of progressing biopsy proven plasmacytoma on exam or imaging; or
5. Bone marrow plasma cells ≥20%;
Cycle 1 day 1 of study treatment must be within 3 months of last exposure to Daratumumab.
Life expectancy >3 months
ECOG PS 0-2
Age ≥18
Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within the Screening Period, defined as:
1. Absolute neutrophil count (ANC) ≥1,000/μL;
2. Platelet count ≥50,000/μL, (≥30,000/μL if bone marrow plasma cells are ≥50% of cellularity);
3. Hemoglobin ≥7.5g/dL;
4. Creatinine clearance ≥60 mL/min (assessed as glomerular filtration rate using the Cockcroft-Gault formula);
5. Alanine aminotransferase or aspartate aminotransferase \<3 x upper limit of normal (ULN);
6. Total bilirubin \<2 x ULN (except for patients with Gilbert's syndrome confirmed by UGT1A1 mutation);
7. Left ventricular ejection fraction ≥50% as assessed by echocardiography or multi-gated acquisition (MUGA) scan; and
8. Must have a minimum level of pulmonary reserve defined as Grade \<2 dyspnea and pulse oxygenation ≥92% on room air;
Prior to first dose of study drug, a woman must be either:
- Not of childbearing potential: premenarchal; postmenopausal (>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone level >40 IU/L or mIU/mL]); permanently sterilized (eg, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
- Of childbearing potential and practicing a highly effective method of birth control for 4 weeks before initiating study treatment that is consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence (when this is in line with the preferred and usual lifestyle of the subject) Note: If the childbearing potential changes after start of the study (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche)
- a woman must begin a highly effective method of birth control, as described above.
A woman of childbearing potential must have 2 negative serum (β human chorionic gonadotropin) or urine pregnancy tests during screening, the first one within 28 days prior to the first dose of study drug and the second within 24 hours prior to the first dose of study drug.
A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug.
Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol and referenced in the informed consent form (ICF).

Exclusion criteria

Exclusion Criteria:

Major concurrent illness or organ dysfunction
Active GVHD requiring systemic corticosteroids in a subject who previously received allogeneic-SCT.
Cord compression or CNS involvement
Recent/Prior active malignancy requiring active therapy 2 years prior to enrollment excluding non-melanoma skin cancer.
Prior life-threatening hypersensitivity to daratumumab or an IMiD
Plasma cell leukemia
Pregnant or lactating females
Men donating sperm during study
Seropositive for human immunodeficiency virus (HIV)
Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)
Chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1 participant (actual)

Study arms

Experimental
Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)
Patients with relapsed or refractory multiple myeloma who have progressed on the combination of Dara + Len + Dex (Cohort A) to be treated with a combination of Dara + Pom + Dex + ATRA (All-Transretinoic Acid)
Drug: Daratumumab · Drug: Pomalidomide · Drug: All-trans retinoic acid · Drug: Dexamethasone
Experimental
Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
Patients with relapsed or refractory multiple myeloma who have progressed on the combination of Dara + Pom + Dex (Cohort B) to be treated with a combination of Dara + Pom + Dex + ATRA (All-Transretinoic Acid)
Drug: Daratumumab · Drug: Pomalidomide · Drug: All-trans retinoic acid · Drug: Dexamethasone

Interventions

DrugDaratumumab
During 28-day treatment cycles, patients will receive Dara 16 mg/kg intravenously (IV) at their current dose upon enrollment onto the study depending on their cycle. They will receive Dara depending on the cycle they are in. If they are on cycles 1-2 then they will receive Dara 16 mg/kg IV on days 1,8,15,22; if they are on cycles 3-6 they will receive Dara 16 mg/kg on days 1 and 15; and if they are on cycle 7 or beyond they will receive Dara 16 mg/kg on day 1.
Also known as: Darzalex
DrugPomalidomide
Pomalidomide will be administered at the patient's currently tolerated dose (4,3, or 2 mg po daily) on days 1-21
Also known as: Pomalyst
DrugAll-trans retinoic acid
ATRA will be administered in a divided dose of twice daily as an oral formulation at 45mg/m2/day for 3 days. The first administration of ATRA will be given in the morning, two days before the scheduled Dara infusion. The last administration of ATRA will be given in the evening of the day that Dara was administered
Also known as: ATRA
DrugDexamethasone
Dexamethasone will be administered at 40 mg once weekly on days 1,8,15 for patients 75 years old and younger and at 20 mg once weekly on days 1,8,15 for patients older than 75.
Also known as: Decadron

What researchers measure

Primary outcomes

Objective Response Rate (Cohort A)
To determine the ORR of the combination of Dara + Pom + Dex + ATRA in patients progressing on Dara + Len + Dex (Cohort A)
Time frame: 12 Months
Incidence of Adverse Events
Incidence of Adverse Events in the combination of Dara + Pom + Dex + ATRA using CTCAE V5 criteria.
Time frame: 12 Months

Secondary outcomes

Objective Response Rate (Cohort B)
To determine the ORR of the combination of Dara + Pom + Dex + ATRA in patients progressing on Dara + Pom + Dex
Time frame: 12 Months
Rate of Stringent Complete Response
To determine the best stringent complete response (sCR)/CR/near CR (nCR) and \>/= very good partial response (VGPR) rates.
Time frame: 12 Months
Incidence of Treatment-Emergent Adverse Events
To define the toxicity using CTCAE V5 criteria.
Time frame: 12 Months
Rate of Minimal Residual Disease Evaluation
To evaluate the status of minimal residual disease (MRD) in patients who achieve sCR, CR, or nCR.
Time frame: 12 Months
Time on Study (TOS)
Duration from start of study treatment to end of study
Time frame: 12 Months
Duration of Response (DOR)
Duration from treatment response to progression
Time frame: 12 Months
Time To Progression (TTP)
Duration from start of study treatment to progression
Time frame: 12 Months
Progression-Free Survival (PFS)
Duration from start of study treatment to PD or death \[regardless of cause\], whichever comes first
Time frame: 12 Months
Overall Survival (OS)
Duration from start of study treatment to death
Time frame: 12 Months

Results

Posted Feb 25, 2025

Participant flow

Participant flow — Overall Study
Milestone	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
Started	1	0
Completed	1	0
Not completed	0	0

Outcome measures

PrimaryObjective Response Rate (Cohort A)

To determine the ORR of the combination of Dara + Pom + Dex + ATRA in patients progressing on Dara + Len + Dex (Cohort A)

Time frame:: 12 Months
Reported as:: Count of participants · Participants

Objective Response Rate (Cohort A)
Participants	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
Objective Response Rate (Cohort A)	1	0

PrimaryIncidence of Adverse Events

Incidence of Adverse Events in the combination of Dara + Pom + Dex + ATRA using CTCAE V5 criteria.

Time frame:: 12 Months
Reported as:: Count of participants · Participants

Incidence of Adverse Events
Participants	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
Incidence of Adverse Events	1	0

SecondaryObjective Response Rate (Cohort B)

To determine the ORR of the combination of Dara + Pom + Dex + ATRA in patients progressing on Dara + Pom + Dex

Time frame:: 12 Months

No measurements were reported for this outcome.

SecondaryRate of Stringent Complete Response

To determine the best stringent complete response (sCR)/CR/near CR (nCR) and \>/= very good partial response (VGPR) rates.

Time frame:: 12 Months
Reported as:: Count of participants · Participants

Rate of Stringent Complete Response
Participants	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
Rate of Stringent Complete Response	0	0

SecondaryIncidence of Treatment-Emergent Adverse Events

To define the toxicity using CTCAE V5 criteria.

Time frame:: 12 Months
Reported as:: Count of participants · Participants

Incidence of Treatment-Emergent Adverse Events
Participants	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
Incidence of Treatment-Emergent Adverse Events	1	0

SecondaryRate of Minimal Residual Disease Evaluation

To evaluate the status of minimal residual disease (MRD) in patients who achieve sCR, CR, or nCR.

Time frame:: 12 Months
Reported as:: Count of participants · Participants

Rate of Minimal Residual Disease Evaluation
Participants	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
Rate of Minimal Residual Disease Evaluation	0	0

SecondaryTime on Study (TOS)

Duration from start of study treatment to end of study

Time frame:: 12 Months
Reported as:: Number · Months

Time on Study (TOS)
Months	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
Time on Study (TOS)	8	—

SecondaryDuration of Response (DOR)

Duration from treatment response to progression

Time frame:: 12 Months
Reported as:: Number · Months

Duration of Response (DOR)
Months	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
Duration of Response (DOR)	8	—

SecondaryTime To Progression (TTP)

Duration from start of study treatment to progression

Time frame:: 12 Months
Reported as:: Number · Months

Time To Progression (TTP)
Months	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
Time To Progression (TTP)	8	—

SecondaryProgression-Free Survival (PFS)

Duration from start of study treatment to PD or death \[regardless of cause\], whichever comes first

Time frame:: 12 Months
Reported as:: Number · Months

Progression-Free Survival (PFS)
Months	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
Progression-Free Survival (PFS)	8	—

SecondaryOverall Survival (OS)

Duration from start of study treatment to death

Time frame:: 12 Months

No measurements were reported for this outcome.

Adverse events

Collected over Adverse events are captured from time of consent through 30 days after the last dose of study drug, approximately 8 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	0/1 (0%)	1/1 (100%)	1/1 (100%)
Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)	—	—	—

Most frequent serious events

Most frequent serious events
Event	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
FeverInvestigations	1/1	—
Febrile NeutropeniaBlood and lymphatic system disorders	1/1	—
RSVInfections and infestations	1/1	—

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
Brain FogginessNervous system disorders	1/1	—
ConstipationGastrointestinal disorders	1/1	—
Constipation IntermittentGastrointestinal disorders	1/1	—
COVID-19Infections and infestations	1/1	—
Dry SkinSkin and subcutaneous tissue disorders	1/1	—
HeadacheNervous system disorders	1/1	—
HyponatremiaMetabolism and nutrition disorders	1/1	—
Nasal CongestionRespiratory, thoracic and mediastinal disorders	1/1	—
NeutropeniaBlood and lymphatic system disorders	1/1	—
Productive CoughRespiratory, thoracic and mediastinal disorders	1/1	—

Baseline characteristics

No patients enrolled in Cohort B

Age, Categorical
Age, Categorical(Participants)	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Total
<=18 years	0	0
Between 18 and 65 years	0	0
>=65 years	1	1

Sex: Female, Male
Sex: Female, Male(Participants)	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)	Total
Female	0	0	0
Male	1	0	1

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)	Total
Hispanic or Latino	0	—	0
Not Hispanic or Latino	1	—	1
Unknown or Not Reported	0	—	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)	Total
American Indian or Alaska Native	0	—	0
Asian	0	—	0
Native Hawaiian or Other Pacific Islander	0	—	0
Black or African American	0	—	0
White	1	—	1
More than one race	0	—	0
Unknown or Not Reported	0	—	0

Region of Enrollment
Region of Enrollment(participants)	Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)	Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)	Total
United States	1	—	1

Study locations

1 site

John Theurer Cancer Center
Hackensack, New Jersey 07601, United States

References and documents

Publications

Kumar SK, Lee JH, Lahuerta JJ, Morgan G, Richardson PG, Crowley J, Haessler J, Feather J, Hoering A, Moreau P, LeLeu X, Hulin C, Klein SK, Sonneveld P, Siegel D, Blade J, Goldschmidt H, Jagannath S, Miguel JS, Orlowski R, Palumbo A, Sezer O, Rajkumar SV, Durie BG; International Myeloma Working Group. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan;26(1):149-57. doi: 10.1038/leu.2011.196. Epub 2011 Jul 29. Erratum In: Leukemia. 2012 May;26(5):1153. Nari, Hareth [corrected to Nahi, Hareth]. PubMed 21799510 ↗
Lee HC. Structure and enzymatic functions of human CD38. Mol Med. 2006 Nov-Dec;12(11-12):317-23. doi: 10.2119/2006-00086.Lee. PubMed 17380198 ↗
Chillemi A, Zaccarello G, Quarona V, Ferracin M, Ghimenti C, Massaia M, Horenstein AL, Malavasi F. Anti-CD38 antibody therapy: windows of opportunity yielded by the functional characteristics of the target molecule. Mol Med. 2013 May 20;19(1):99-108. doi: 10.2119/molmed.2013.00009. PubMed 23615966 ↗
Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, Rabin N, Orlowski RZ, Komarnicki M, Suzuki K, Plesner T, Yoon SS, Ben Yehuda D, Richardson PG, Goldschmidt H, Reece D, Lisby S, Khokhar NZ, O'Rourke L, Chiu C, Qin X, Guckert M, Ahmadi T, Moreau P; POLLUX Investigators. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Oct 6;375(14):1319-1331. doi: 10.1056/NEJMoa1607751. PubMed 27705267 ↗
Chari A, Suvannasankha A, Fay JW, Arnulf B, Kaufman JL, Ifthikharuddin JJ, Weiss BM, Krishnan A, Lentzsch S, Comenzo R, Wang J, Nottage K, Chiu C, Khokhar NZ, Ahmadi T, Lonial S. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood. 2017 Aug 24;130(8):974-981. doi: 10.1182/blood-2017-05-785246. Epub 2017 Jun 21. PubMed 28637662 ↗
Nijhof IS, Groen RW, Lokhorst HM, van Kessel B, Bloem AC, van Velzen J, de Jong-Korlaar R, Yuan H, Noort WA, Klein SK, Martens AC, Doshi P, Sasser K, Mutis T, van de Donk NW. Upregulation of CD38 expression on multiple myeloma cells by all-trans retinoic acid improves the efficacy of daratumumab. Leukemia. 2015 Oct;29(10):2039-49. doi: 10.1038/leu.2015.123. Epub 2015 May 15. PubMed 25975191 ↗
Nijhof IS, Casneuf T, van Velzen J, van Kessel B, Axel AE, Syed K, Groen RW, van Duin M, Sonneveld P, Minnema MC, Zweegman S, Chiu C, Bloem AC, Mutis T, Lokhorst HM, Sasser AK, van de Donk NW. CD38 expression and complement inhibitors affect response and resistance to daratumumab therapy in myeloma. Blood. 2016 Aug 18;128(7):959-70. doi: 10.1182/blood-2016-03-703439. Epub 2016 Jun 15. PubMed 27307294 ↗
Dimos JT, Rodolfa KT, Niakan KK, Weisenthal LM, Mitsumoto H, Chung W, Croft GF, Saphier G, Leibel R, Goland R, Wichterle H, Henderson CE, Eggan K. Induced pluripotent stem cells generated from patients with ALS can be differentiated into motor neurons. Science. 2008 Aug 29;321(5893):1218-21. doi: 10.1126/science.1158799. Epub 2008 Jul 31. PubMed 18669821 ↗
Wichterle H, Lieberam I, Porter JA, Jessell TM. Directed differentiation of embryonic stem cells into motor neurons. Cell. 2002 Aug 9;110(3):385-97. doi: 10.1016/s0092-8674(02)00835-8. PubMed 12176325 ↗
Collins SJ. The role of retinoids and retinoic acid receptors in normal hematopoiesis. Leukemia. 2002 Oct;16(10):1896-905. doi: 10.1038/sj.leu.2402718. PubMed 12357341 ↗
Kantarjian HM, Keating MJ, Walters RS, Estey EH, McCredie KB, Smith TL, Dalton WT Jr, Cork A, Trujillo JM, Freireich EJ. Acute promyelocytic leukemia. M.D. Anderson Hospital experience. Am J Med. 1986 May;80(5):789-97. doi: 10.1016/0002-9343(86)90617-0. PubMed 3458366 ↗
Cordonnier C, Vernant JP, Brun B, Heilmann MG, Kuentz M, Bierling P, Farcet JP, Rodet M, Duedari N, Imbert M, et al. Acute promyelocytic leukemia in 57 previously untreated patients. Cancer. 1985 Jan 1;55(1):18-25. doi: 10.1002/1097-0142(19850101)55:13.0.co;2-b. PubMed 3855265 ↗
Tallman MS, Kwaan HC. Reassessing the hemostatic disorder associated with acute promyelocytic leukemia. Blood. 1992 Feb 1;79(3):543-53. No abstract available. PubMed 1732003 ↗
Chomienne C, Ballerini P, Balitrand N, Daniel MT, Fenaux P, Castaigne S, Degos L. All-trans retinoic acid in acute promyelocytic leukemias. II. In vitro studies: structure-function relationship. Blood. 1990 Nov 1;76(9):1710-7. PubMed 2224120 ↗
Tallman MS, Andersen JW, Schiffer CA, Appelbaum FR, Feusner JH, Ogden A, Shepherd L, Willman C, Bloomfield CD, Rowe JM, Wiernik PH. All-trans-retinoic acid in acute promyelocytic leukemia. N Engl J Med. 1997 Oct 9;337(15):1021-8. doi: 10.1056/NEJM199710093371501. PubMed 9321529 ↗
Ogata A, Nishimoto N, Shima Y, Yoshizaki K, Kishimoto T. Inhibitory effect of all-trans retinoic acid on the growth of freshly isolated myeloma cells via interference with interleukin-6 signal transduction. Blood. 1994 Nov 1;84(9):3040-6. PubMed 7949175 ↗
Siegel D, Niesvizky R, Miller WH Jr, Busquets X, Kumar R, MIchaeli J: All trans retinoic acid (ATRA) and interferon alfa (IFNa) synergistically inhibit myeloma cell growth and induce retinoic acid receptor alfa (RARa) expression. Blood 80:121a:1992 (abstr, supple 1).
Musto P, Falcone A, Sajeva MR, D'Arena G, Bonini A, Carotenuto M. All-trans retinoic acid for advanced multiple myeloma. Blood. 1995 Jun 15;85(12):3769-70. No abstract available. PubMed 7780162 ↗
Frerichs KA et al, Efficacy and safety of daratumumab combined with all-trans retinoic acid in relapsed/refractory multiple myeloma: results of the Phase ½ Dara/Atra study. Blood (2019) 134 S:1:1826.

Study documents

Protocol and statistical analysis plan · Nov 29, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04700176
Lead sponsor: Hackensack Meridian Health
Collaborators: Janssen, LP
Responsible party: Sponsor
First posted: Jan 7, 2021
Start date: May 2, 2022
Primary completion: Nov 15, 2023
Completion: Nov 15, 2023
Results posted: Feb 25, 2025
Last update: Feb 25, 2025

Study contacts

Noa Biran, MD

principal investigator · Hackensack Meridian Health

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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